AU2023208151B2

AU2023208151B2 - Medical Luer connector

Info

Publication number: AU2023208151B2
Application number: AU2023208151A
Authority: AU
Inventors: Jean M. Bonaldo; Pavel T. Miller
Original assignee: Halkey Roberts Corp
Current assignee: Halkey Roberts Corp
Priority date: 2013-11-18
Filing date: 2023-07-27
Publication date: 2025-06-26
Anticipated expiration: 2036-10-18
Also published as: BR112018007750A2; AU2021206900A1; EP3362123A4; NZ741983A; CA3002146A1; EP3362123A1; AU2016341847A1; BR112016011279A2; US20170106181A1; BR112016011279B1; CA3002146C; US9839774B2; WO2017070098A1; JP6999548B2; AU2023208151A1; JP2018531099A; US20150141937A1; CN108348676A; MX2018004624A; ES2926370T3

Abstract

#$%^&*AU2023208151B220250626.pdf##### [00108] ABSTRACT [00109] A Luer medical connector having a male Luer body for connection with a female Luer assembly which includes a female Luer body, a fluid channel insert within the female Luer body, an elastomeric seal between the female Luer body and the male Luer body, and an elastomeric stopper at a proximal end of the female Luer body. [00108] ABSTRACT 27 Jul 2023 [00109] A Luer medical connector having a male Luer body for connection with a female Luer assembly which includes a female Luer body, a fluid channel insert within the female Luer body, an elastomeric seal between the female Luer body and the male Luer body, and an elastomeric stopper at a proximal end of the female Luer body. 2023208151 [00108] ABSTRACT 27 Jul 2023 [00109] A Luer medical connector having a male Luer body for connection with a female Luer assembly which includes a female Luer body, a fluid channel insert within the female Luer body, an elastomeric seal between the female Luer body and the male Luer body, and an elastomeric stopper at a proximal end of the female Luer body. 2023208151

Description

MEDICAL LUER MEDICAL LUER CONNECTOR CONNECTOR

[0011

[001] CROSS-REFERENCE TO CROSS-REFERENCE INVENTIONS RELATED INVENTIONS TO RELATED

[0021

[002] This application This application isis aa divisional divisional of ofAustralian AustralianPatent PatentApplication Application No. No. 2021206900, 2021206900,

which isis aa divisional which divisional of ofAustralian AustralianPatent PatentApplication Application No. No. 2016341847, theentire 2016341847, the entire contents contentsofof which arehereby which are herebyincorporated incorporated by by reference. reference.

[0031

[003] BACKGROUND INVENTION THEINVENTION BACKGROUNDOFOFTHE

[0041

[004] Field the Invention of the Field of Invention

[0051

[005] This invention relates This invention to Luer relates to connectors. Luer connectors.

[0061

[006] Description the Background of the Description of Art Background Art

[0071

[007] Presently, Luerconnectors Presently, Luer widelyused arewidely connectorsare to to used connect connect medical medical devices devices involved involved in in transferring medical fluids, and can be found for example on syringes, catheters, and connectors for transferring medical fluids, and can be found for example on syringes, catheters, and connectors for

IV tubing. IV tubing. Luer connectors comprise Luer connectors compriseinterlocking interlockingmale male(outer) (outer)and andfemale female(inner) (inner)portions portionswhich which are slightly tapered are slightly taperedsosoasastotoconnect connect via via a pressure a pressure or interference or interference fit in fit in a fluid-tight a fluid-tight manner. manner. When When the male and female portions are joined with a threaded connection, the connection is referred to as the male and female portions are joined with a threaded connection, the connection is referred to as

aa Luer lock, which Luer lock, opens and which opens anddoses dosesbybytwisting. twisting. AAnon-threaded non-threadedLuer Luer connection connection is is generally generally

referred to as a Luer plug or Luer slip. referred to as a Luer plug or Luer slip.

[0081

[008] Maleand Male andfemale female Luer Luer connector connector portions portions cooperate cooperate to communicatively to communicatively couple couple separate devices separate devices oror pieces pieces ofofmedical medicaltubing tubingandand form form a single a single flow flow pathway. pathway. For example, For example, one one length of tubing length of can be tubing can beattached attachedtotoaarnale male Luer Luerconnector connectorandand another another length length of tubing of tubing can can be be

attached to attached to aa female Luerconnector. female Luer connector.TheThe separate separate lengths lengths of tubing of tubing can can thenthen be placed be placed into into

fluid fluid

- 1- communication by by coupling thethe male Luer connector portion and and the the female LuerLuer connector 30 May 2025 2023208151 30 May 2025 communication coupling male Luer connector portion female connector portion. portion.

[009]

[009] In some In circumstances,Luer some circumstances, Luerconnectors connectorsmaymay be be connected connected to and to and

disconnected from flow lines on at least a daily basis. Repeated usage of a Luer connector, disconnected from flow lines on at least a daily basis. Repeated usage of a Luer connector,

however,may however, maycause cause theconnector the connector to to leakororbecome leak become contaminated contaminated withwith particulate particulate material, material,

such as particles that detach from the septum of the connector and/or cotton fibers front such as particles that detach from the septum of the connector and/or cotton fibers front 2023208151

swabs usedtoto clean swabs used clean the the connectors. connectors. Connectors Connectorsmust mustremain remain leak leak freeand free andreliably reliablyavoid avoid introduction introduction of of contaminants. contaminants.

[0010]

[0010] A variety A variety of of Luer connectionsare Luer connections are known. known.U.S. U.S.Patent PatentNos. Nos.5,273,533 5,273,533 andand

5,306,243 to Bonaldo, 5,306,243 to Bonaldo,for for example, example,disclose discloseaamedical medicalconnector connectorhaving having anan elastomeric elastomeric

element element inin theform the form ofseptum of a a septum or fluid or fluid barrier barrier disposed disposed in a twoinpart a two part housing. plastic plastic housing. The The septum is pierced septum is pierced by by aa pointed cannula in pointed cannula in the the connector whenmaking connector when makingthethe connection connection to to thethe

fluid fluid flow flow line. line.U.S. U.S.Patent PatentNo. No.5,947,954 5,947,954 to toBonaldo discloses aa needleless Bonaldo discloses needleless connector connector which which

includes includes attached attached relatively relativelyrotatable rotatablemale maleand and female female Luer Luer connector parts with connector parts with an an

eccentrically positioned eccentrically positioned flow flow passageway passageway atatthe the inner inner end end of of the the female Luer connector. female Luer connector. Further needleless Luer connectors include that of U.S. Patent No. 7,118,560, also to Further needleless Luer connectors include that of U.S. Patent No. 7,118,560, also to

Bonaldo. Bonaldo.

[0011]

[0011] Therefore, preferred Therefore, preferred embodiments embodiments of of thisinvention this inventionseek seektotoprovide provideanan improvement which improvement which overcomes overcomes the aforementioned the aforementioned inadequacies inadequacies of theofprior the prior art devices art devices and and

provides an provides an improvement improvement which which is is a significantcontribution a significant contributiontotothe the advancement advancement of of the the

medicalLuer medical Luerconnector connectorart. art.

[0012]

[0012] Thesepreferred These preferred embodiments embodiments should should be be construed construed to be to be merely merely illustrativeofof illustrative

someofofthe some the more moreprominent prominent featuresand features andapplications applicationsofofthe theintended intendedinvention. invention.Many Many other other

beneficial results can be attained by applying the disclosed invention in a different manner or beneficial results can be attained by applying the disclosed invention in a different manner or

modifyingthe modifying theinvention inventionwithin withinthe thescope scopeofofthe the disclosure. disclosure. Accordingly, other advantages Accordingly, other advantages and aa fuller and fullerunderstanding understanding of of the the invention invention may be had may be had by by referring referring to to the the summary ofthe summary of the invention and invention and thethe detailed detailed description description ofpreferred of the the preferred embodiment embodiment in additioninto addition the scopetoof the scope of the invention the invention defined defined by the claims by the claims taken taken in in conjunction conjunction with with the the accompanying drawings. accompanying drawings.

-2-

[0012a] The reference in this specification to any prior publication (or information 30 May 2025 2023208151 30 May 2025

[0012a] The reference in this specification to any prior publication (or information

derived from derived fromit), it), orortotoany anymatter matterwhich which is isknown, known, is isnot notan anacknowledgment acknowledgment ororadmission admissionoror

any form of suggestion that that prior publication (or information derived from it) or known any form of suggestion that that prior publication (or information derived from it) or known

matter forms matter forms part part of of the the common generalknowledge common general knowledge in the in the fieldofofendeavor field endeavor to to which which this this

specification relates. specification relates.

[0013]

[0013] SUMMARYOF SUMMARY OFTHE THE INVENTION INVENTION 2023208151

[0013a]

[0013a] A medical A medicalconnector connectorassembly assembly having having a longitudinal a longitudinal axis,the axis, themedical medical connector assembly connector assemblycomprising: comprising: a male a male luerbody luer body having having a proximal a proximal end, end, a distalend, a distal end,and anda a flow channelextending flow channel extendingbetween between saidproximal said proximal endend andand said said distalend, distal end,said saiddistal distal end end comprisingaatapered comprising taperedmale maleluer luermember member having having an an open open end end adapted adapted to connected to be be connected to a to a fluid fluid conduit; conduit; aafemale female luer luerassembly, assembly, comprising: comprising: a a female luer body female luer havingaa proximal body having proximalend, end, a distal a distalend, end,and andaaflow flowchannel channel extending extending between said proximal between said proximalend endofofsaid saidfemale femaleluer luer bodyand body andsaid said distal distal end end of of said said female female luer luer body, body, said said proximal proximal end end of of said said female female luer luer body body

forming forming aa female femaleluer luer member member forreceiving for receivinga amale maleluer luermember member offluid of a a fluid transferdevice; transfer device; said female said luer body female luer comprisinga acam body comprising campost; post;a afluid fluid channel channelinsert insert having having aa proximal end, aa proximal end,

distal distal end, end,and and aaflow flow channel channel extending extending between saidproximal between said proximalend endofofsaid saidfluid fluid channel channel insert andsaid insert and saiddistal distalend endofofsaid said fluid fluid channel channel insert, insert, wherein wherein saidchannel said flow flow channel of said fluid of said fluid

channel insert is offset from said longitudinal axis at said distal end of said fluid channel channel insert is offset from said longitudinal axis at said distal end of said fluid channel

insert, insert, said fluid channel said fluid channelinsert insertfurther further comprising comprising an annular an annular medial medial walldistal wall at said at saidenddistal of end of said fluid channel insert, said annular medial wall engaging said distal end of said female luer said fluid channel insert, said annular medial wall engaging said distal end of said female luer

body; said body; said proximal proximalend endofofthe the fluid fluid channel insert comprising channel insert a tubular comprising a tubular conduit conduit having an having an

opening opening atat aa proximal proximal end end of said of said tubular tubular conduit; conduit; saidchannel said fluid fluid channel insertcomprises insert further further comprises an an annular barb shaped annular barb shapedflange flangeextending extendingoutwardly outwardlyfrom from said said tubularconduit tubular conduitbetween between an an

outwardlyextending outwardly extendingmedial medialwall walland andsaid saidproximal proximalendend of of saidfluid said fluidchannel channelinsert; insert; an an elastomeric seal elastomeric seal having a proximal having a end, aa distal proximal end, distal end, end,and and aaflow flow channel channel extending between extending between

said proximal end of said elastomeric seal and said distal end of said elastomeric seal, said proximal end of said elastomeric seal and said distal end of said elastomeric seal,

wherein said flow channel of said elastomeric seal is offset from said longitudinal axis at said wherein said flow channel of said elastomeric seal is offset from said longitudinal axis at said

proximalend proximal endofofsaid said elastomeric elastomeric seal seal and is adapted and is adapted to to provide provide fluid fluid communication with communication with

said flow channel of said fluid channel insert at said distal end of said fluid channel insert; said flow channel of said fluid channel insert at said distal end of said fluid channel insert;

and an and an elastomeric elastomeric stopper stopper having havingaa proximal proximalend endand anda adistal distal end, end, said said elastomeric stopper elastomeric stopper

having a flush surface at said proximal end of said elastomeric stopper, said flush surface having a flush surface at said proximal end of said elastomeric stopper, said flush surface

comprisingaaslit comprising slit totoallow allow an anopening opening to to be be formed by deforming formed by deformingsaid saidproximal proximalend endofofsaid said

-3- elastomeric stopper, stopper, said said elastomeric elastomeric stopper stopper further furthercomprising comprising an an annular annular groove adaptedtoto 30 May 2025 2023208151 30 May 2025 elastomeric groove adapted mate with said annular barb shaped flange of said fluid channel insert; and wherein said distal mate with said annular barb shaped flange of said fluid channel insert; and wherein said distal end of end of said said female luer body female luer connects with body connects withsaid said proximal proximalend endofofsaid said male maleluer luer body bodywith withanan interference interference fit fitand andforms forms aaflow flowchannel channel through through said said medical connector assembly medical connector assemblywhen when said said flow channel flow channelof of said said male luer body male luer andsaid body and said flow flowchannel channelofofsaid said female femaleluer luer body bodyare are aligned; wherein aligned; the proximal wherein the proximalend endofofsaid said male maleluer luer body bodyfurther further comprises comprisesa acam camgroove groove andand a protrusion; a protrusion; said saidprotrusion protrusionextending extending into intothe thecam cam groove groove at at each each end end of of the the cam cam groove; groove; 2023208151 said cam said grooveextending cam groove extendingaround around a portionofofa acircumference a portion circumferenceofof theproximal the proximal end end of of the the male luer male luer body, body, said said cam groovebeing cam groove beingshaped shapedto to receivesaid receive saidcam cam postofofthe post thefemale femaleluer luer body and to define a range of rotation of the female luer body with respect to the male luer body and to define a range of rotation of the female luer body with respect to the male luer body, with body, with the the cam campost postsnapping snappingover overthe theprotrusion protrusiontoto retain retain the the female female luer luer body in one body in one of of a fully a fully engaged engaged position position and and a a disengaged position. disengaged position.

[0013b]

[0013b] The The termterm ‘comprise’ 'comprise' and variants and variants of the of the termterm suchsuch as ‘comprises’ as 'comprises' or ‘comprising’ or 'comprising'

are used herein to denote the inclusion of a stated integer or stated integers but not to exclude are used herein to denote the inclusion of a stated integer or stated integers but not to exclude

any other integer or any other integers, unless in the context or usage an exclusive any other integer or any other integers, unless in the context or usage an exclusive

interpretation of the term is required. interpretation of the term is required.

[0013c] Another

[0013c] Another aspect aspect of the of the present present invention invention provides provides a medical a medical connector connector assembly assembly

having aa longitudinal having longitudinal axis, axis, the themedical medical connector connector assembly comprising:a amale assembly comprising: maleluer luerbody body having aa proximal having proximalend, end,aa distal distal end, end, and and aa flow flow channel channel extending betweensaid extending between saidproximal proximalend end and said and said distal distalend, end,said saiddistal distalendendcomprising comprisinga atapered taperedmale maleluer luermember havingan member having anopen open end adapted end adaptedto to be be connected connectedtoto aa fluid fluid conduit; conduit; aa female female luer luer body body having having aa proximal end, aa proximal end,

distal end, distal end,and and aaflow flow channel channel extending extending between saidproximal between said proximalend endofofsaid saidfemale femaleluer luerbody body and said distal end of said female luer body, said proximal end of said female luer body and said distal end of said female luer body, said proximal end of said female luer body

formingaa female forming femaleluer luer member member forreceiving for receivinga amale male luermember luer memberof aoffluid a fluid transferdevice; transfer device; said female said luer body female luer comprisinga acam body comprising campost; post;a afluid fluid channel channelinsert insert having having aa proximal end, aa proximal end,

distal end, distal end,aaflow flowchannel channel extending extending between said proximal between said proximalend endofofsaid saidfluid fluid channel insert channel insert

and said distal end of said fluid channel insert, and an annular medial wall at said distal end and said distal end of said fluid channel insert, and an annular medial wall at said distal end

of said fluid of said fluid channel channelinsert, insert,said said annular annular medial medial wall wall engaging engaging saidend said distal distal endfemale of said of said female luer body;said luer body; saidproximal proximal end end of fluid of the the fluid channel channel insert insert comprising comprising a tubular aconduit tubularhaving conduit having an opening an openingat at aa proximal endof proximal end of said said tubular tubular conduit; conduit; an an elastomeric elastomeric seal seal having having aa proximal proximal

end, aa distal end, distalend, end,and anda aflow flowchannel channel extending extending between said proximal between said proximalend endofofsaid said elastomeric elastomeric seal and said distal end of said elastomeric seal, wherein said flow channel of said seal and said distal end of said elastomeric seal, wherein said flow channel of said

- 3a 3a -- elastomeric seal seal is isadapted adapted to toprovide provide fluid fluidcommunication withsaid said flow flowchannel channelofofsaid said 30 May 2025 2023208151 30 May 2025 elastomeric communication with fluid channelinsert fluid channel insertatatsaid saiddistal distalendend of of said said fluid fluid channel channel insert; insert; and and an an elastomeric elastomeric stopper stopper having a proximal end and a distal end, said elastomeric stopper having a flush surface at said having a proximal end and a distal end, said elastomeric stopper having a flush surface at said proximal end of said elastomeric stopper, said flush surface comprising a slit to allow an proximal end of said elastomeric stopper, said flush surface comprising a slit to allow an opening to be opening to be formed formedbybydeforming deforming saidproximal said proximal endend of of said said elastomeric elastomeric stopper; stopper; and and whereinsaid wherein said distal distal end end of of said saidfemale female luer luerbody body connects connects with with said said proximal end of proximal end of said said male male luer luer body with an body with an interference interference fit fitand andforms forms aaflow flow channel channel through through said said medical connector medical connector 2023208151 assemblywhen assembly when saidflow said flowchannel channel of of saidmale said male luerbody luer body andand said said flow flow channel channel of of said said female female luer luer body are aligned; body are aligned; wherein the proximal wherein the endof proximal end of said said male maleluer luer body bodyfurther further comprises comprisesaa camgroove cam grooveand anda aprotrusion; protrusion;said saidprotrusion protrusion extending extendinginto into the the cam camgroove grooveatateach each circumferential end circumferential of the end of the cam groove;said cam groove; said cam camgroove grooveextending extending around around a portion a portion of of a a circumferenceofofthe circumference the proximal proximalend endofofthe themale maleluer luerbody, body,said said cam camgroove groovebeing being shaped shaped to to receive said cam post of the female luer body and to define a range of rotation of the female receive said cam post of the female luer body and to define a range of rotation of the female luer body luer with respect body with respect to to the the male male luer luer body, body, with with the the cam cam post post snapping over the snapping over the protrusion protrusion to retain the female luer body in one of a fully engaged position and a disengaged position. to retain the female luer body in one of a fully engaged position and a disengaged position.

[0013d] A further

[0013d] A further aspect aspect of of thethe present present invention invention provides provides a medical a medical connector connector assembly assembly

having aa longitudinal having longitudinal axis axis comprising: a male comprising: a luer body male luer havingaaproximal body having proximalend, end,a adistal distal end, end,

and aa flow and channelextending flow channel extendingbetween between saidproximal said proximal endend andand distalend, distal end,said saiddistal distal end end comprisingaatapered comprising taperedmale maleluer luermember member having having an an open open end end adapted adapted to connected to be be connected to a to a fluid fluid conduit; conduit; aafemale female luer luerassembly, assembly, comprising: comprising: a a female luer body female luer havingaa proximal body having proximalend, end, a distal a distalend, end,and andaaflow flowchannel channel extending extending between said proximal between said proximalend endand anddistal distal end, end, said said proximalend proximal endofofsaid said female femaleluer luer body bodyforming forminga afemale femaleluer luermember memberforfor receiving receiving a male a male

luer member of a fluid transfer device; said female luer body comprising a cam post; a fluid luer member of a fluid transfer device; said female luer body comprising a cam post; a fluid

channel insert channel insert having a proximal having a end, aa distal proximal end, distal end, end,and and aaflow flow channel channel extending betweensaid extending between said proximal end and said distal end, wherein said flow channel of said fluid channel insert is proximal end and said distal end, wherein said flow channel of said fluid channel insert is

offset from said longitudinal axis at said distal end of said fluid channel insert, said fluid offset from said longitudinal axis at said distal end of said fluid channel insert, said fluid

channel insert further comprising an annular medial wall at its distal end, said annular medial channel insert further comprising an annular medial wall at its distal end, said annular medial

wall engaging wall said distal engaging said distal end end of of said said female female luer luerbody; body; said saidproximal proximal end end of of the the channel channel

insert comprising a tubular conduit having an opening at its proximal end; said fluid channel insert comprising a tubular conduit having an opening at its proximal end; said fluid channel

insert insert further furthercomprises comprises an an annular annular barb barb shaped flange extending shaped flange outwardlyfrom extending outwardly fromsaid saidtubular tubular conduit between conduit betweenananoutwardly outwardlyextending extending medial medial wall wall andand said said proximal proximal end end of said of said fluid fluid

channel insert; an elastomeric seal having a proximal end, a distal end, and a flow channel channel insert; an elastomeric seal having a proximal end, a distal end, and a flow channel

extending between extending betweensaid saidproximal proximalendend and and distalend, distal end,wherein whereinsaid saidflow flowchannel channel of of saidseal said sealisis

- 3b - 3b -- offset fromsaid saidlongitudinal longitudinal axisaxis at said proximal end is and is adapted to fluid provide fluid 30 May 2025 2023208151 30 May 2025 offset from at said proximal end and adapted to provide communication with said flow channel of said fluid channel insert at said distal end of said communication with said flow channel of said fluid channel insert at said distal end of said fluid channel insert; and an elastomeric stopper having a proximal end and a distal end, said fluid channel insert; and an elastomeric stopper having a proximal end and a distal end, said stopper having stopper having a flush a flush surface surface at its at its proximal proximal end,flush end, said said surface flush surface comprising comprising a slit to a slit to allow an allow an opening openingtoto be be formed formedbybydeforming deforming said said proximal proximal end, end, said said elastomeric elastomeric stopper stopper further comprising further an annular comprising an annular groove grooveadapted adaptedtotomate matewith withsaid saidannular annularbarb barbshaped shaped flangeofof flange said fluid channel insert; and wherein said distal end of said female luer assembly connects said fluid channel insert; and wherein said distal end of said female luer assembly connects 2023208151 with said with said proximal endof proximal end of said said male male luer luer body withan body with aninterference interference fit fit and and forms forms a a flow flow channel through channel throughsaid said medical medicalconnector connectorassembly assembly when when saidsaid flow flow channels channels are are aligned; aligned; whereinthe wherein the proximal proximalend endofofsaid saidmale maleluer luerbody bodyfurther furthercomprises comprisesa acam cam groove groove andand protrusions; said protrusions; said protrusions protrusions extending extending into into the thecam cam groove at each groove at each end thereof, said end thereof, saidcam cam grooveextending groove extendingaround arounda aportion portionofofthe thecircumference circumferenceofofthe theproximal proximalend endofofthe themale maleluer luer bodyand body andbeing beingshaped shapedtotoreceive receivesaid saidcam campost postofofthe thefemale femaleluer luerbody, body,said said insert insert comprisingananinterlocking comprising interlockinggroove grooveand anda aprojection projectionprecluding precludingrelative relative rotation rotation between said between said female luer female luer body andsaid body and said fluid fluid channel insert, and channel insert, and wherein wherein said said groove is formed groove is on the formed on the annular distal wall of said fluid channel insert instead of the annular medial wall, the annular distal wall of said fluid channel insert instead of the annular medial wall, the projection is longitudinally extended from the distal wall of the female luer body and projection is longitudinally extended from the distal wall of the female luer body and projected toward a distal direction, the interlocking groove is engaged by the projection. projected toward a distal direction, the interlocking groove is engaged by the projection.

[0014]

[0014] Preferred embodiments Preferred provide embodiments provide a furtherimproved a further improved medical medical connector connector which which

includes includes a a female Luer end female Luer endhaving havingananelastomeric elastomericstopper stopperwhich which achieves achieves zero zero displacement displacement

and thereby reduces the likelihood of contaminant entry to the fluid flow path of the and thereby reduces the likelihood of contaminant entry to the fluid flow path of the

connector. connector.

[0015]

[0015] Theforegoing The foregoinghas hasoutlined outlinedrather rather broadly broadly the the more morepertinent pertinent and andimportant important features of the present invention in order that the detailed description of the invention that features of the present invention in order that the detailed description of the invention that

follows may be better understood so that the present contribution to the art can be more fully follows may be better understood so that the present contribution to the art can be more fully

appreciated. Additional features of the invention will be described hereinafter which form the appreciated. Additional features of the invention will be described hereinafter which form the

subject of the claims of the invention. It should be appreciated by those skilled in the art that subject of the claims of the invention. It should be appreciated by those skilled in the art that

the conception the and the conception and the specific specific embodiment disclosedmay embodiment disclosed may be be readily readily utilizedasasaabasis utilized basis for for modifyingorordesigning modifying designingother otherstructures structures for for carrying carrying out out the the same purposes of same purposes of the the present present

invention. It should also be realized by those skilled in the art that such equivalent invention. It should also be realized by those skilled in the art that such equivalent

constructions do not depart from the spirit and scope of the invention as set forth in the constructions do not depart from the spirit and scope of the invention as set forth in the

appendedclaims. appended claims.

- 3c 3c --

Jul 2023

[00161

[0016] BRIEF DESCRIPTION OF BRIEF DESCRIPTION OF THE THE DRAWINGS DRAWINGS 2023208151 27

[00171

[0017] Foraafuller For fuller understanding understanding of the of the nature nature and objects and objects of the of the invention, invention, reference reference

should be should had to be had to the the following detailed description following detailed description taken taken in in connection connection with with the the accompanying accompanying

drawings. The drawings. Thedrawings drawings suffixed suffixed with with thethe letter "A" letter "A"refer referto to the the first first embodiment ofthe embodiment of the parent parent

application. The application. drawingssuffixed The drawings suffixedwith withthe theletter letter "B" refer to "B" refer tothe thesecond second embodiment embodiment

employingananextended employing extended blunttube blunt tubechannel channelinsert. insert. The The drawings drawings suffixed suffixed with with thethe letter"C" letter refer "C" refer

to aa third to thirdembodiment employing embodiment employing a spiketube a spike tubechannel channel insert. The insert. The drawings drawings suffixed suffixed with with thethe

letter "D" letter "D" refer refertotoa a fourth embodiment fourth employing"open" embodiment employing "open"andand "closed" "closed" indicatorspositioned indicators positioned atat

120 degrees 120 degreesso so they they are are visible visible at any at any angle. angle.

[00181

[0018] Figures 11 A, Figures A, BB &&CCare areaatop top plan plan view viewofofthe the present present medical medical Luer Luerconnector connector

assembly. assembly.

100191

[0019] A, BB &&CCare Figures 22 A, Figures eacha aside areeach side elevation viewof elevation view ofthe the present Luer medical Luer present medical

connector assembly. connector assembly.

[00201

[0020] Figures 33 A, Figures A, BB &&CCare areeach eacha asectional sectional view viewofofthe the present present medical medical Luer Luer

connector assembly connector assemblyalong alongline line2-2 2-2ofofFigures Figures2.2.

[00211

[0021] Figures 44 A, Figures B &&CCare A, B areeach eacha aperspective perspective view viewofofthe the male male Luer Luercomponent componentof of thethe

present Luer present connector. Luer connector.

[00221

[0022] Figures 55 A, BB &&CCare Figures areeach eacha a rear rear elevation elevation view ofthe view of the male male Luer componentofof Luer component

the present the present Luer connector. Luer connector.

100231

[0023] Figures 66 A, Figures B &&CCare A, B eachaa side areeach elevation view side elevation of the view of the male male Luer componentofof Luer component

the present the present Luer connector. Luer connector.

[00241

[0024] Figures 77 A, BB &&CCare Figures areeach eacha asectional sectional view of the view of the male male Luer Luer component component ofof the the

presentLuer present Luerconnector connector alongalong lineof6-6 line 6-6 of Figures Figures 6. 6.

-4-

[00251

[0025] Figures 88 A, Figures B &&CCare A, B eacha atop areeach top plan plan view ofthe viewof the male male Luer component Luercomponent of of thethe

present Luer present connector. Luer connector.

[00261

[0026] Figures 99 A, Figures B &&CCare A, B eachaasectional areeach view of sectional view the male of the male Luer component Luer component of of the the

2023208151

presentLuer present Luerconnector connector along along line line 8-8Figures 8-8 of of Figures 8. 8.

[00271

[0027] Figures 10 Figures 10 A, A, BB &&C Care areeach eacha aperspective perspectiveview viewofofaacontamination contaminationcap capfor forthe the

male Luer male Luercomponent componentof of thethepresent presentLuer Luerconnector. connector.

100281

[0028] Figures 11 A, Figures 11 eacha aperspective areeach A, BB &&C Care viewofofthe perspectiveview the female femaleLuer component Luercomponent of of

the present the present Luer Luer connector. connector.

[00291

[0029] Figures 12 Figures eacha aside areeach A, BB &&C Care 12 A, side elevation elevation view ofthe viewof female Luer the female component Luercomponent

of the of presentLuer the present Luer connector. connector.

[00301

[0030] Figures 13 Figures eacha asectional areeach A, BB &&C Care 13 A, viewof sectional view the female ofthe Luer component female Luer componentof of

the present the presentLuer Luer connector connector along along line 12-12 line 12-12 of Figures of Figures 12. 12.

[0031]

[0031] Figures1414 Figures A,A, B &BC& C each are are each an elevation an elevation view ofview of theend the distal distal end of the of the female female

Luer component Luer componentofof thepresent the presentLuer Luerconnector. connector.

100321

[0032] Figures 15 Figures 15 A, A, BB &&C Care areeach eacha aperspective perspectiveview viewofofthe the female femaleLuer Luerassembly assemblyof of

the present the presentLuer Luer connector. connector.

[00331

[0033] Figures 16 Figures 16 A, A, BB &&C Care areeach eacha afront front elevation elevation view view of of the the female female Luer Luer assembly assembly

of the of presentLuer the present Luer connector. connector.

[00341

[0034] Figures 17 Figures 17 A, A, BB &&C Care areeach eacha arear rear elevation elevation view view of of the the female Luer assembly female Luer assemblyofof

the present the presentLuer Luer connector. connector.

[0035]

[0035] Figures 18 Figures 18 A, A, BB &&C Care areeach eacha aside side elevation elevation view viewof ofthe the female female Luer Luerassembly assembly

of the of presentLuer the present Luerconnector. connector.

100361

[0036] Figures 19 Figures A, BB &&C Care 19 A, eacha asectional areeach viewof sectional view ofthe the female Luercomponent female Luer componentof of

-5-

Jul 2023

the present the presentLuer Luer connector connector along along line line 18-18 18-18 of Figures of Figures 18. 18.

2023208151 27

[00371

[0037] Figures 20 Figures 20 A, A, BB &&C Care areeach eacha asectional sectional view view of ofthe the female female Luer Luercomponent componentof of

the present the presentLuer Luerconnector connector along along line line 19-19 19-19 ofFigures of Figures 19. 19.

100381

[0038] are each Figures2121A,A,B &B C&areC each Figures view of view a perspective a perspective of the insert the channel channel insert of the of the

female Luer female Luer assembly assemblyofofthe thepresent present Luer Luerconnector. connector.

[00391

[0039] Figures22 Figures 22 A,A, B &BC& C each are are each a sidea elevation side elevation view ofview of the insert the channel channelof insert the of the

[00401

[0040] Figures2323A,A,B &BC&areC each Figures are each a sectional a sectional view ofview of the channel the channel insert of insert of the the female female

Luer component Luer componentofof thepresent the presentLuer Luerconnector connectoralong alongline line22-22 22-22ofofFigures Figures22. 22.

[00411

[0041] Figures2424A,A, Figures B &B C& C each are are each a reara elevation rear elevation view ofview of the insert the channel channelof insert the of the

100421

[0042] Figures2525A,A,B &B C&areC each Figures are each a front a front elevation view ofview elevation of the insert the channel channelof insert the of the

[00431

[0043] Figures 26 Figures 26 A, A, BB &&C Care areeach eacha aside side elevation elevation view view of ofthe the elastomeric elastomeric stopper stopper of of

the female the Luer assembly female Luer assemblyofofthe the present present Luer Luer connector. connector.

[00441

[0044] Figures2727A, Figures A, B &BC & C each are are each a sectional a sectional view ofview of theelastomeric the elastomeric stopper ofstopper the of the

female Luer female Luer assembly assemblyofofthe thepresent present Luer Luerconnector connectoralong alongline line 26-26 26-26ofofFigures Figures 26. 26.

[00451

[0045] Figures 28 Figures 28 A, A, BB &&C Care areeach eacha aperspective perspectiveview viewofofthe the seal seal component componentofofthe the

present Luer present connector. Luer connector.

[00461

[0046] Figures2929A,A,B &B C&areC each Figures are each a reara elevation rear elevation view ofview of the the seal sealpresent of the of the Luer present Luer

connector. connector.

[00471

[0047] Figures3030A,A,B &BC&areC each Figures are each a sidea elevation side elevation view ofview of the the seal sealpresent of the of the Luer present Luer

connector.Figures connector. Figures 31 31 is aisfront a front elevation elevation viewview of theof the of seal seal theof the present present Luer connector. Luer connector.

-6-

[00481

[0048] are each Figures3232A,A,B &BC&areC each Figures a sectional view ofview a sectional the seal of seal of the of the present the present Luer Luer

connectoralong connector along line line 31-31 31-31 of Figures of Figures 31. 31.

[00491

[0049] Figures A, BB &&C Care 33A, Figures 33 areeach perspective view eacha aperspective showing viewshowing thethe indicators for indicatorsfor

indicating the indicating the "ON" and"OFF" "ON" and "OFF"positions. positions.

[0050]

[0050] referencecharacters Similarreference Similar characters refer refer to similar to similar parts parts throughout throughout the several the several views views of of

the drawings. the drawings.

-7-

[00511

[0051] DESCRIPTIONOF DETAILED DESCRIPTION DETAILED THE PREFERRED OF THE EMBODIMENT PREFERREDEMBODIMENT

[00521

[0052] Definitions Definitions

[00531

[0053] As used As used herein, herein, the the following terms and following terms and variations variations thereof thereof have the meanings have the meanings

2023208151

givenbelow, given below, unless unless a different a different meaning meaning is clearly is clearly intended intended by theincontext by the context in which which such term issuch term is

used. used.

[00541

[0054] The Theterms terms "a," "a," "an," andand "an," "the" "the" and similar and similar referents referents used herein to beare herein used are to be

construedtotocover construed cover both both the the singular singular andplural and the the plural unless unless theirinusage their usage in indicates context context indicates

otherwise. otherwise.

[00551

[0055] "Annular" componentororportion refers aa component "Annular" refers portionthereof forminga aring, thereofforming andisis inclusive ring, and inclusive

of aa partial of partial or or complete complete ring-shaped ring-shaped structure, structure, for example, for example, a tubular a tubular structure, structure, a "c-ashape," a "c- shape," "u- a "u

shape,"ororanan"o-shape." shape," "o-shape."

100561

[0056] andgroove" "Camand "Cam groove" fittingororcoupling fitting to aa connection refers to couplingrefers connection between two betweentwo

componentsininwhich components which a projectionoror"cam" a projection "cam"on on oneone component component fits fits intointo a "cam a "cam surface" surface" or or

grooveininanother groove another component, component, in particular in particular in to in order order to aeffect effect a seal against seal against a seal ora gasket. seal or gasket.

100571

[0057] "Connected"and "Connected" "coupled" and"coupled" refertotocomponents refer components that that areare eitherdirectly either connected directly connected

or coupled or to another coupled to another element or which element or whichare are separated separated by byintervening interveningelements. elements. When Whenan an element element

is referred is to as referred to as being being"directly "directlyconnected" connected" or "directly or "directly coupled" coupled" to another to another element, element, there are there no are no

intervening elements intervening elements present. present.

[00581

[0058] "Comprise"and "Comprise" andvariations variationsofofthe theterm, term, such suchasas "comprising" "comprising"and and"comprises," "comprises," areare

not intended not intendedtotoexclude exclude other other additives, additives, components, components, integers integers or steps.or steps. "Elastic" "Elastic" refers refers to a to a

material or component material which component which can can be be bent bent oror otherwisedeformed otherwise deformed elasticallyby by elastically a predetermined a predetermined

force but force butwhich which will will return return to its to its original original shape shape when when the applied the applied force isforce is removed. removed.

100591

[0059] "Elastic" refers "Elastic" refers totoa amaterial materialoror component which component can be which can be bent bent or or otherwise otherwise

-8-

Jul 2023

deformed elastically by a predetermined force but which will return to its original shape when deformed elastically by a predetermined force but which will return to its original shape when

2023208151 27

the applied force is removed. the applied force is removed.

[00601

[0060] "Elastomer" and"elastomeric" "Elastomer" and refertoto an "elastomeric" refer elastic polymer an elastic material such polymer material as natural such as natural

rubber, silicone, silicone rubber, and the like. rubber, silicone, silicone rubber, and the like.

[00611

[0061] refers to "Elongated"refers "Elongated" to aa configuration configuration or shape having or shape having aa length length which is longer which is longer

than its width. than its width.

100621

[0062] "Flange" refers to a projecting rim, collar, or ring on a structural element of a "Flange" refers to a projecting rim, collar, or ring on a structural element of a

componentofofthe component thepresent presentdevice devicewhich whichsupports supportsororprovides providesa aplace placeofofattachment attachmentforforother other

components. components.

[00631

[0063] "Fluid conduit" and "conduit" refer to a structure for receiving and/or transferring "Fluid conduit" and "conduit" refer to a structure for receiving and/or transferring

fluids, for example medical tubing, a catheter, a drain tube, an access port, or a needle. fluids, for example medical tubing, a catheter, a drain tube, an access port, or a needle.

100641

[0064] "Inward"and "Inward" "inwardly"mean and"inwardly" in in mean a direction thethe toward a directiontoward longitudinal axisoror longitudinalaxis

center of the present device or of a component part. center of the present device or of a component part.

[00651

[0065] "Longitudinal" refers to a direction or orientation aligned with the length (longer "Longitudinal" refers to a direction or orientation aligned with the length (longer

portion) of the present device or a component thereof. portion) of the present device or a component thereof.

[00661

[0066] "'Male Luer "Male Luermember" member" refers refers to to a component a component of the of the present present device device comprising comprising a a

projecting conduit having an open distal (outer) end and which tapers toward its distal end in projecting conduit having an open distal (outer) end and which tapers toward its distal end in

order to allow connection to another fluid conduit. order to allow connection to another fluid conduit.

[00671

[0067] "Outward"and "Outward" and"outwardly" "outwardly" mean mean in aindirection a direction away away fromfrom the longitudinal the longitudinal axisaxis

or center of the present device or of a component part. or center of the present device or of a component part.

[00681

[0068] "Rim"refers "Rim" refers to to an an outer outer edge of aa component edge of component ofofthe the present present device. device.

[00691

[0069] Relative terms, Relative terms, such as "lower", such as "lower", "bottom", "below", "upper", "bottom", "below", "upper","top" "top" or or "above," "above,"

may be used herein to describe one element's relationship to another element as illustrated in the may be used herein to describe one element's relationship to another element as illustrated in the

-9-

Figures.Such Figures. Such relative relative terms terms are intended are intended to encompass to encompass differentdifferent orientations orientations of the of the device in device in

additiontotothe addition theorientation orientationdepicted depicted in the in the Figures. Figures.

[00701

[0070] Luer Connector Luer

100711

[0071] Figures 1I through Figures through 33 illustrate illustratethe present the connector present assembly connector assembly1.1.The The assembly assembly

comprises aa female comprises female Luer Luerbody body100 100inina aproximal proximalportion portion2 2ofofthe the assembly assembly1 Iand anda amale maleLuer Luer

body1010inina distal body a distalportion portion 4. 4. As As shown shown in Figures in Figures 1A-3A, IA-3A, the distalthe distal4 portion portion 4 optionally optionally includes includes

a cap a 15 for cap 15 covering aa male for covering male Luer Luermember member20.20. TheThe cap cap 15 includes 15 includes a tapered a tapered inner inner surface surface 18 18 in in

ordertotomate order mate with with thethe exterior exterior surface surface of male of the the male Luer member Luer member 20, and in20, and in heat-sterilized heat-sterilized

embodimentsalso embodiments alsopreferably preferablyincludes includesvents vents1616(see (see Figure Figure10). 10). As Asshown shownin in Figure3,3,the Figure the

assembly assembly I further 1 further includes includes a seal a seal 170 aand 170 and a channel channel insert 150, 150,together insertwhich which with together with the male the male

Luer body Luer body1010forms formsa aflow flowchannel channelfor forfluids fluids being being transferred transferred through through the connector 1. the connector 1.

100721

[0072] Male Luer Body Male Body

[0073]

[0073] The male The body10 10 Luerbody maleLuer ofof presentconnector thepresent the assembly connectorassembly 1 is shown I isshown in in Figure Figure 4 4

through Figure through Figure 9. 9. The Themale maleLuer Luer body body 10 10 includes includes a proximal a proximal endend 12, 12, a distalend a distal end14, 14,ananupper upper

side 11, side 11, aa lower side13,13,andand lowerside twotwo lateral lateral sides sides 16 18. 16 and andThe 18.upper The side upper 11 side 11lower and/or and/or sidelower 13 side 13

preferablyinclude preferably include a relatively a relatively flat,planar flat, planar portion portion 19order 19 in in order to allow to allow betterbetter gripping gripping of the of the

assembly1 when assembly I when being being handled handled by aparticularly by a user, user, particularly when when it is it is necessary necessary to turn or to turntheor twist twist the

assembly1, 1,andand assembly to to deter deter rolling rolling of the of the malemale Luer Luer body body 10 when 10 when placed on placed on a flatInsurface. a flat surface. the In the

illustrated embodiments, illustrated embodiments, the the planar planar portion portion 19 is 19 is triangular triangular in shape, in shape, i.e.that i.e. such suchonethat one

longitudinalend longitudinal end is is visually visually distinguishable distinguishable from from the other the other longitudinal longitudinal end, in end, orderin toorder to facilitate facilitate

the orientation the orientation of ofthe theconnector connectorassembly assembly 1, 1, though though other other non- non- symmetrical shapes can symmetrical shapes can also also be be

used. AtAtthe used. thedistal distalend end14,14, thethe male male LuerLuer body body 10 includes 10 includes a longitudinally a longitudinally projecting projecting male Luer male Luer

member2020 member having having a proximal a proximal endend 22 22 andand a distalend a distal end24.24.The The male male Luer Luer member member 20 comprises 20 comprises

- 10-

Jul 2023

an inner lumen an 25. The lumen 25. Theproximal proximalend end2222comprises comprisesa proximal a proximal opening opening 23 one 23 at at one endend of of thethe lumen lumen

2023208151 27

25, and 25, andthe thedistal distalend end2424 comprises comprises a distal a distal opening opening 27 at 27 at the the end, other otherwhich end,together which form together a form a

portion ofofthe portion thefluid fluidflow flowpath path through through the present the present connector connector assemblyassembly 1. Theofdiameter 1. The diameter the outerof the outer

surface 29 of the surface the male male Luer Luer member member 2020 decreasesfrom decreases from thethe proximal proximal endend 22 22 to to thethe distalend distal end2424inin

order toto form order forma ataper. taper.

[00741

[0074] distal end The distal The end 24 24 of of the the male male Luer Luer member member 2020 preferablyextends preferably extendslongitudinally longitudinally

beyondthethe beyond distalendend.34 distal ofannular, 34 of an an annular, preferably preferably circumferential circumferential flange flange or collaror 30collar.30 which which

surrounds the surrounds the male male Luer Luermember member20.20. Between Between the the distal distal endend 34 34 andand thethe proximal proximal andand 32 the 32 of of the

collar 30, collar 30, the the inner innersurface surface3535 is is preferably preferably provided provided with grooves with grooves 37 tothe 37 to engage engage theofthreads threads of

another fluid another fluid transfer transferdevice devicetoto which whichthe thepresent presentconnector connectorassembly assembly I1 can can be be connected connected to to form form

a fluid a flowpath. fluid flow path.

100751

[0075] At the At the distal distalend end24 24 of ofthe themale maleLuer Luermember 20, the member 20, the male male Luer Luerbody body1010

comprises aa receptacle comprises receptacle 40 40 for for receiving receiving the the female female Luer Luer assembly 105having assembly 105 havinga aproximal proximalend end42, 42,

a distal a distal end 44,and end 44, andananinner inner surface surface 45. 45. The The distal distal end end 44 44 includes includes seal41pegs seal pegs 41O-ring and an and an O-ring

groove4949forfor groove retaining retaining a seal a seal 170 170 in the in the receptacle receptacle 40. 40. In the In the embodiment, first first embodiment, there there were were

providedthree provided threeseal seal pegs pegs 41 angularly 41 angularly equidistantly equidistantly about about the the end distal distal enda44 44 and and apeg locator locator 41L peg 41L

for properly for angularly properly angularly orientating orientating the the sealseal 170 during 170 during assembly. assembly. In the In the second andsecond third and third

embodiments,two embodiments, twoseal sealpegs pegs4141are areprovided providedalong alongwith witha aconsiderably considerablywider wider locatorpeg locator peg41L 41L to to

facilitate easier facilitate easier orientation duringassembly. orientation during assembly.

100761

[0076] The themale end1212ofofthe proximalend The proximal Luerbody maleLuer body10 10 furtherincludes further annular,semi- includesananannular, semi

circular cam circular cam groove 50. As groove 50. As best best seen seen in in Figure Figure 5, 5, the thecam cam groove 50 extends groove 50 extends around aroundaaportion portion of of

the circumference the of the circumference of the proximal end 12 proximal end 12 of of the the male Luerbody male Luer body10, 10,and andisis shaped shapedto to receive receive and and

cooperate with cooperate with aa cam post 110 cam post 110ononthe the female femaleLuer Luerbody body100. 100. In In thesecond the second andand third third

- II

embodiments,there embodiments, thereisis additionally additionally provided provided aa protrusion 50P extending into 50P extending into the the cam groove5050atat cam groove

each end each end thereof thereof that that are are engaged engaged by aa longitudinally-extending longitudinally-extending cam post 110 cam post 110 on onthe the underside underside of of

the female the Luer body female Luer body100 100ininalignment alignmenttherewith. therewith. The The cam cam post post 110110 rides rides in in thecam the cam groove groove 50 50

andsnaps and snapsover over thethe protrusions protrusions 50P 50P to to provide provide increased increased turning turning resistance resistance to assure to assure that that the valve the valve

I is 1 is rotated openonce rotated open oncethethe male male LuerLuer connection connection (e.g., (e.g., from anfrom an intravenous intravenous line) connected line) is fully is fully connected

to the to connector1 and the connector I and conversely, conversely, to assure to assure thatvalve that the the valve 1 is rotated 1 is rotated closed closed before before the male the Luermale Luer

connectionis isdisengaged. connection disengaged. The protrusions The protrusions 50P 50P also also provides provides a tactile indication a tactile indication to to the nurse the nurse

indicating when indicating the male when the male Luer Luerconnection connectionisis fully fully engaged engagedor or disengaged disengagedfrom fromthe thevalve valve1I asasthe the

valveopens valve opensor or closes, closes, respectively. respectively.

[00771

[0077] the first In the In firstembodiment, embodiment, the the proximal 12 of proximal end 12 of the the male male Luer Luer body 10also body 10 also

preferably comprises preferably comprises aa semi-circular, semi-circular, annular annular guard guard or or shield shield60 60which which extends around aa portion extends around

of the of the periphery periphery of of the theproximal proximal end end 12 12 and and has an inner inner surface surface 61. 61.The The guard guard 60 60 extends extends

longitudinallyandand longitudinally proximally proximally ofproximal of the the proximal end 42 end 42receptacle of the of the receptacle 40, to 40, in order in help orderprevent to help prevent

unintentional rotation unintentional rotationof ofthe thefemale femaleLuer Luerbody body 100, 100, which might accidentally which might accidentally disconnect disconnect it it from from

the male the maleLuer Luer body body 10. This 10. This a particular is a particular issueissue whenare when users users are wearing wearing protectiveprotective gloves, gloves, which which

decreasethe decrease thedexterity dexterity of of thethe user. user. TheThe guard guard also helps also helps to prevent to prevent externally externally spilled spilled fluid fluid from from

getting in getting in between between the the female female Luer body100 Luer body 100and andthe themale maleLuer Luerbody body 10.10. In In thethesecond second andand third third

embodiments,the embodiments, theannular annularguard guardshield shieldextends extends360 360degrees degreesaround around theperiphery the peripheryofof theproximal the proximal

end 12. end 12.

100781

[0078] Female Luer Assembly Female Assembly

[00791

[0079] receptacle40 40 Thereceptacle The of of thethe male male Luer Luer body body 10 (see10 Figure (see 7) Figure 7) is to is adapted adapted receivetoa receive a

female Luer female Luer assembly assembly105. 105.The Thefemale female Luer Luer assembly assembly 105 105 (Figs. (Figs. 15-20) 15-20) includes includes a female a female LuerLuer

body(Figs. body (Figs.11-14), 11-14), a seal a seal 170170 (Figs. (Figs. 28-32) 28-32) atdistal at the the distal end end 44 of 44 theof the receptacle receptacle 40, a 40, a channel channel

112-

insert 150(Figs. insert 150 (Figs.21-25) adjacent 21-25)adjacent the the sealseal and aand 170, 170, a stopper stopper 160 (Figs. (Figs. at 160 26-27) 26-27) at the proximal the proximal end end

42 ofofthe 42 receptacle40.40. the receptacle

[00801

[0080] As best As seen in best seen 11-14, the Figures 11-14, in Figures the female Luer body female Luer body 100 comprisesa aproximal 100comprises end proximalend 2023208151

102, aa distal 102, distal end end104, 104,and and an an interior interior 101 101 for for retaining retaining the channel the channel 150 and150 insert insert and stopper stopper 160 (as 160 (as

shownininFigures shown Figures 1919and and20). 20). Proximal Proximalend end102 102preferably preferablyincludes includesthreads threads107 107for formating matingwith with

the grooves the groovesofof another another fluid fluid transfer transfer device. device. The distal The distal endof 104 end 104 ofthe Luer the female female bodyLuer body 100 is 100 is

to fit adapted to adapted fitwithin withinthe thereceptacle 4040ofof receptacle male thethe Luer male body Luer body10. 10.When When the the female female Luer body 100 Luer body 100

is retained is withinthe retained within themale male Luer Luer body, body, the outer the outer surface surface 106 of 106 of the proximal the proximal end 104 isend 104 is adjacent adjacent

to, and to, preferablyisisinincontact and preferably contactwith, with, thethe inner inner surface surface 45the 45 of the receptacle ofreceptacle 40 of 40 the of theLuer male male Luer

body1010(Figure body (Figure 3). 3).

[00811

[0081] As seen in best seen As best Figure 13, in Figure interior101 the interior 13, the ofofthethe 101 female Luer female body Luer 100 comprises body100 comprises

an inner surface an surface 103 103 for for retaining retainingcomponents of the components of the female female Luer assembly105. Luer assembly 105.AtAtproximal proximalend end

102, the 102, the interior interior101 101includes includesananinwardly inwardlyextending extending annular annular wall wallor orsurface surface114 114which which extends extends

inwardly from inwardly fromaa proximal endofofthe proximalend the inner inner surface surface 103. 103. This This inwardly extending wall inwardly extending wall 114 114helps helpstoto

retain the retain the elastomeric elastomericstopper stopper 160 160 (as described (as described further further below). below). In theembodiment, In the first first embodiment, a a

proximal inner proximal inner surface surface 116 116 extends extends proximally proximallyfrom fromthe theinwardly inwardlyextending extendingwall wall114114 toward toward thethe

proximalendend proximal 102, 102, ending ending at exterior at exterior proximal proximal surfacesurface 112. 112. At a Atend distal a distal end of the of the inner inner surface surface

103, and outwardly 103, outwardly extending extendingannular annularwall wallororsurface surface 132 132 extends extendsoutwardly, outwardly,ininorder order to to help

retain the retain the channel channelinsert insert150. 150. A distal A distal inner inner surface surface 136 frusto 136 frusto conically conically extendsextends distally distally from the from the

outwardly outwardly extending extending surface surface 132, ending 132, ending as an exterior as an exterior distal surface distal surface 134. 134.

[0082]

[0082] The female The body100100 Luerbody femaleLuer preferably includesa acam preferablyincludes campost 110 post110 which which rides rides in in the the

earngroove cam groove5050ofofthe themale Luerbody male Luer body10.10.The The cam cam post post 110 110 allows allows thethe female female Luer Luer bodybody 100 100 to to

be rotated be rotateduntil untilthe thecam cam post post 110110 reaches reaches one one of theof the lateral lateral ends ends 56 56oforthe or 58 58 cam of the cam groove 50 groove 50

- 13-

(Figure 5), (Figure 5), thereby thereby preventing preventing over-torqueing over-torqueing of of the the female female Luer Luer body 100. body 100.

[00831

[0083] In the first In the firstembodiment, embodiment, the the earn cam post 110 and earn 110 and groove5050could cam groove couldalso alsocooperate cooperate

prevent separation to prevent to separation of of the themale male Luer Luer body and the 10 and body 10 the female female Luer Luer body body100 100under conditionsofof underconditions 2023208151

high pressure. high pressure. The The cam campost post110 110extends extendslongitudinally longitudinallytoward towardthe thedistal distal end end 104 104 of ofthe the female female

Luer body Luer body100 100from fromananannular, annular,preferably preferablycircumferential circumferential flange flange 120 120extending extendingoutwardly outwardlyfrom from a a

medialportion medial portionof of thethe female female LuerLuer body body 100. 100. The The120 flange flange 120 facilitates facilitates rotation rotation of of the the female Luerfemale Luer

body100100 body when when attaching attaching it to it ortodetaching or detaching it the it from from theLuer male male Luer body body 10 (at the 10 (at the distal end distal 104) end 104)

and/oranother and/or anotherfluid fluid transfer transfer device device (at (at the the proximal proximal end The end 102). 102). Thesurface outer outer 121 surface of the121 of the flange flange

120 preferably 120 preferably abuts abuts the the inner inner surface surface61 61of ofthe theguard guard60 60ofofthe male the maleLuer Luerbody body 10 10 when the male when the male

Luer body Luer body1010and andfemale femaleLuer Luerbody body 100100 areare connected. connected.

[00841

[0084] In second and the second In the third embodiments, and third the flange embodiments, the 120 extends flange 120 the proximal overthe extendsover proximal

end 12 end 12 of of the the male Luer body male Luer body1010and andthe thecam campost post110 110isispositioned positionedunderneath underneaththe theflange flange120. 120.

[0085]

[0085] As best As seen in best seen in Figures Figures 19 and 20, the the female Luer body female Luer 100engages body 100 engagesand andretains retainsaa

channel insert channel insert 150, 150, which is shown which is in Figures 21-25. A shown in channel insert A channel insert 150 150 generally generally comprises comprises aa

proximal end proximal end152, 152, aa distal distal end end 154, 154, and and an an interior interiorchannel channel 140 140 extending extending between the proximal between the proximal

end 152 end 152 and andthe the distal distal end end 154. 154. The The proximal end 152 proximal end 152ofofthe the channel channel insert insert 150 150 generally generally

comprises aa preferably comprises preferably tubular tubular conduit 153 153 having having an an opening opening149 149atatits its proximal end. proximal end.

[00861

[0086] In the In the first first embodiment, at or embodiment, at or adjacent adjacent the the opening opening 149, 149, the the interior interior surfacesurface 155 of 155 of

the channel 140 the 140 preferably preferably comprises comprises generally generally longitudinally longitudinally extending extending grooves grooves157. 157. The Thedistal distal

end 154 end 154 of of the the channel insert 150 channel insert 150 includes includes an an outwardly extending medial outwardly extending medialsurface surface or or wall wall 148, 148,

whichextends which extendsoutwardly outwardlyfrom from theouter the outersurface surfaceofofthe the conduit conduit 153. 153. The Theoutwardly outwardlyextending extending

medial wall medial wall 148 148 meets meetsananannular annularmedial medialsurface surfaceororwall wall 146, 146, which whichextends extendsgenerally generallyfrustro- frustro

conically(longitudinally conically (longitudinallyandand distally) distally) to outwardly to an an outwardly extending extending distal distal wall wall 144. 144.outer At the At the outer

- 14-

Jul 2023

perimeterofofthe perimeter theoutwardly outwardly extending extending distaldistal wallan144, wall 144, an annular annular distal or distal surface surface or extends wall 142 wall 142 extends

2023208151 27

outwardly outwardly to to the the distalsurface distal surface 151 151 of the of the channel channel insertinsert 150. 150. An An annular annular barb-shaped barb-shaped flange or flange or

ring 141 extends ring extends outwardly outwardlyfrom fromthe thetubular tubular conduit conduit 153 153between betweenthe theoutwardly outwardly extending extending medial medial

wall 148 wall 148 and and the the proximal end152 proximal end 152ofofthe the channel channelinsert insert 150. 150.

[00871

[0087] the second In the In second and third embodiments, and third the channel embodiments, the 140isis lengthened channel140 lengthenedto to extend extend to to

the inside the inside end endofofthe thestopper stopper 160. 160. The annular The annular medial medial surface surface or wall or wall 146 146 less is formed is formed less frustro- frustro

conically. In conically. In both both the the first firstand second and secondembodiments the channel embodiments the channel 160 160 comprises comprisesa ablunt bluntend end

opening 149 opening 149whereas whereasininthe thethird third embodiment, embodiment,the thechannel channel160160 comprises comprises a spiked a spiked endend with with

opposingside opposing side openings openings 149 149located locatedimmediately immediatelybelow below itsits pointedtip. pointed tip. The Theextended-length extended-length

channel 160 channel 160 that that extends to to the the end end of of the theunderside underside of ofthe thestopper stopper160 160advantageously advantageously precludes precludes

a vacuum a beingestablished vacuum being establishedwithin withinthe the stopper stopper 160 160upon upondisengagement disengagementof of thethe male male Luer Luer

connectorfrom connector from thethe valve valve I that, 1 that, in the in the casecase offirst of the the first embodiment, embodiment, would sometimes would sometimes hinder the hinder the

stopper160 stopper 160from from returning returning to normal to its its normal at rest at rest closed closed position position upon disengagement upon disengagement of the male of the male

Luer connector. Luer connector. With Withsuch sucha avacuum, vacuum,thethe stopper stopper 160160 would would need need to "burp" to "burp" to take to take in in airtoto air

eliminatethe eliminate thevacuum, vacuum, so that so that the the stopper stopper wouldwould return return to its normal to its normal at restposition. at rest closed closed position.

Taking in Taking in air air would then compromise would then compromise thedesired the desiredzero zerodisplacement displacementfeature featureofofthe thevalve valve1.1.

[00881

[0088] As best As seen in best seen in Figure Figure 23, 23, the the channel 140 extends from channel 140 the opening from the 149distally opening 149 distally

to aa distal to distal channel opening channel opening 147.147. The The distal distal channel channel openingopening 147 meets147 meets and/or and/or is integrally is integrally formed formed

with aa proximal with side channel proximal side opening145 channel opening 145for for aa side side channel 140a. 140a. The Thedistal distal channel 140a meets channel 140a meets

the interior the interior channel channel140140 at at an an angle, angle, in order in order to position to position the channel the channel distal distal openingopening 143 away 143 fromaway from

the center the centerofofthe thedistal distalsurface surface151151 of of thethe channel channel insert insert 150. 150. The The use of use of an opening an offset offset opening 143 143

ensuresthat ensures thatthis thisopening opening aligns aligns withwith the the corresponding corresponding openingopening on 170, on the seal the seal 170, thereby thereby allowing allowing

fluid flow fluid flow through through the connector 1, only connector 1, only when the female when the female Luer Luer body body100 100and andthe thechannel channelinsert insert

- 15-

150 which 150 it retains which it retainsare aresecured securedtotothe male the maleLuer Luerbody body 10. 10.When the female When the female Luer Luerbody body100 100isisnot not

appropriatelyrotated appropriately rotated andand securely securely retained retained within within theLuer the male male Luer body 10, body 10, the the opening 143opening of the 143 of the

channelinsert channel insert150150 will will notnot align, align, or or notnot fully fully align, align, withwith the corresponding the corresponding 179 on the179 opening opening on the

seal 170 seal 170and andthereby thereby block block fluid fluid flow flow through through the 1. the valve valve 1. Blocking Blocking fluid flow fluid flow through through valve 1 is valve I is

importanttotoachieve important achieve a zero a zero displacement displacement valve 1valve (i.e., (i.e., a a valve valve 1 that 1does thatnotdoes notinjection allow allow injection or or

withdrawal of withdrawal offluid fluid from the IV from the line or IV line orother othercomponent to which component to which the the valve valve 11 is is connected connected when when

the access the accessdevice deviceis is engaged engaged or disengaged or disengaged from from the the1).valve valve 1).

[00891

[0089] The distal end The distal end 104 of the 104 of Luer body female Luer the female 100generally body 100 engagesthe generally engages channel thechannel

insert 150 insert 150atat the the distal distal end end154154 of of thethe channel channel insert insert 150. 150. As for As seen seen for example example in Figurein19, Figure the 19, the

exterior distal exterior distal surface surface134 134of of female female LuerLuer body body 100distal 100 abuts abuts wall distal 144wall 144channel of the of theinsert channel insert

150; distal 150; distal inner innersurface surface136136 of of thethe female female Luer Luer body body 100 100theabuts abuts thewall medial medial wall 146 of the 146 of the

channel insert channel insert 150; 150; and and outwardly extending surface outwardly extending surface 132 132of ofthe the female female Luer Luerbody body100 100abuts abuts

medialwall medial wall148148 of of thethe channel channel insert insert 150. 150. In order In order to securely to securely retain retain and andthe orient orient the insert channel channel insert

withinthe within thefemale female Luer Luer bodybody 100, 100, in theinfirst the first embodiment, embodiment, a plurality a plurality of longitudinal of longitudinal grooves 159grooves 159

are provided are providedonon thethe medial medial wallwall 146 Figs. 146 (see (see Figs. 21-23) 21-23) whereas whereas in the in the second andsecond third and third

embodiments,there embodiments, thereisis only only one, one, extra-wide extra-wide longitudinal longitudinal groove groove 159 159and anditit is is formed on the formed on the wall wall

142 instead 142 insteadofofwall wall146. 146.

[00901

[0090] In the In the first firstembodiment, embodiment, the the grooves grooves 159 are engaged 159 are by longitudinally engaged by longitudinally extending extending

projectionsororcams projections cams 138 138 on distal on the the distal innerinner surface surface 136 of136 the of the distal distal end of end of theLuer the female female body Luer body

100 (see 100 (see Figs. Figs. I11 Iand and 13-14) 13-14) whereas in the whereas in the second and third second and third embodiments, thesingle, embodiments, the single, wide wide

groove 159 groove 159is is engaged engagedbybya asingle single extra-wide extra-wide projection projection 138 138 longitudinally longitudinally extending extending from fromthe the

distalwa1l134. distal wall 134. In In allall embodiments, embodiments, the projection(s) the projection(s) 138 prevent 138 prevent or resist or resist rotational rotational movement movement

of the of the channel channel insert insert150 150 when engagedbybythe when engaged thegroove(s) groove(s)159 159ofofthe the channel channel insert insert 150. 150.

- 16-

Jul 2023

[00911

[0091] Afurther A furtheradvantage advantage of the of the present present channel channel insertinsert 150 is 150 that isitthat contact contact it prevents prevents

2023208151 27

betweenthe between the interior interior 101 101 of of the the female female Luer Luer body 100 and body 100 andfluids fluids passing passing through the connector through the connector

assembly1. 1.This assembly This eliminates eliminates the possibility the possibility of contamination of contamination of such of suchduefluids fluids due towith to contact contact the with the

interior 101. interior 101.

[0092]

[0092] The female The femaleLuer Luerassembly assembly105105 furthercomprises further comprises an an axially(longitudinally) axially (longitudinally)

defbrmableelastomeric deformable elastomericstopper stopper160, 160,best best seen seen in in Figures Figures 26 and27. 26 and 27. The stopper 160 The stopper 160generally generally

comprisesa hollow, comprises a hollow, longitudinal longitudinal structure structure havinghaving bellowsbellows or accordion-like or accordion-like folds 161, folds 161, with each with each

fold being fold beingatatthe thejuncture junctureof of twotwo opposed opposed surfaces surfaces 163 on 163 on the exterior the exterior 165stopper 165 of the of the160. stopper The 160. The

stopperisis mounted stopper mounted or positioned or positioned around around the channel the channel insert insert 150, such150, thatsuch that the surface the interior interior166surface 166

of the of the stopper stopper160 160surrounds surrounds the the exterior exterior surface surface of theof the tubular tubular conduitconduit 153channel 153 of the of theinsert channel insert

(as seen (as seen inin Figures Figures3,3,19,19,andand 20,20, forfor example). example). When When force isforce is exerted exerted against against the theproximal closed, closed, proximal

face 182 face 182ofofthe thestopper stopper 160160 by aby a syringe syringe or other or other fluid fluid transfer transfer device, device, the proximal the proximal face 182 face is 182 is

urgeddistally urged distallytoward towardthethe proximal proximal endof152 end 152 the of the channel channel insert insert 150, and 150, and thesurfaces the opposed opposed surfaces

163 ofofthe 163 theaccordion-like accordion-like outer outer surface surface 165urged 165 are are urged together, together, thereby thereby collapsing collapsing the160stopper the stopper 160

andreducing and reducingit it ininlength. length.This This allows allows a syringe, a syringe, for example, for example, to be inserted to be inserted into theinto the proximal proximal end end

of the of the female female Luer body100. Luer body 100.

[00931

[0093] In the In the first firstembodiment, embodiment, when the proximal when the proximalend end162 162ofofthe the stopper stopper 160 160reaches reaches the the

proximalendend proximal 152 152 of the of the channel channel insertinsert 150,syringe 150, the the syringe willthepush will push the material elastic elastic material of the ofthe

proximalface proximal face 182182 intointo the the opening opening 149 of149 the of the channel channel 140 140 of the of theinsert channel channel 150.insert 150. The The elastic elastic

materialofofthe material theproximal proximalfaceface 182 182 will will be urged be urged into into the the longitudinally longitudinally extending extending grooves grooves 157 of 157 of

the channel the channelinsert insert150, 150, which which thereby thereby gripmaterial grip the the material of the of the stopper stopper 160. The 160. The160 stopper stopper will 160 will

resist twisting resist twistingwhen when gripped gripped in in this thisway, which is way,which isadvantageous advantageous because because twisting tends to twisting tends to weaken weaken

and/ortear and/or tearthe thematerial, material,creating creating a risk a risk of of introducing introducing an infection. an infection.

- 17-

[00941

[0094] In the In the second second embodiment, sincethe embodiment, since theopening opening149 149isispositioned positionedimmediately immediately

underneath the underneath the inner inner surface surface of of the the proximal proximal end 162 of end 162 of the the stopper stopper 160, 160, the thesyringe syringeimmediately immediately

pushes the elastic material of the proximal face 182 over the opening 149 of the channel 140 so pushes the elastic material of the proximal face 182 over the opening 149 of the channel 140 so

that the slit 181 immediately opens to encircle the channel 140 and form a seal therewith, thereby that the slit 181 immediately opens to encircle the channel 140 and form a seal therewith, thereby

establishing fluid establishing fluidflow flowpath pathbetween between the the syringe syringe and and the the channel channel 140. 140. In In the the third thirdembodiment, embodiment,

the syringe immediately pushes the elastic material of the proximal face 182 over the spike to the syringe immediately pushes the elastic material of the proximal face 182 over the spike to

open the open the slit slit 181 181whereupon further inward whereupon further inward movement movement pushes pushes thethe slitpast slit pastthe the side side openings openings 149 149

to seal and establish fluid flow path between the syringe and the channel 140. to seal and establish fluid flow path between the syringe and the channel 140.

[00951

[0095] The stopper is made from an elastic, preferably elastomeric material such as The stopper is made from an elastic, preferably elastomeric material such as

silicone, so that once a fluid transfer device is removed from the female Luer body, the proximal silicone, SO that once a fluid transfer device is removed from the female Luer body, the proximal

face 182 will resiliently move proximally to its original closed position. When not in use, the face 182 will resiliently move proximally to its original closed position. When not in use, the

proximal face 182 of the stopper 160 is preferably flush with proximal wall 112 of the female proximal face 182 of the stopper 160 is preferably flush with proximal wall 112 of the female

Luer body Luer body100, 100,SOso that that both both the the proximal wall 112 proximal wall 112 and and the the proximal proximal face face 182 182can canbebeswabbed swabbed

with a disinfectant. In one embodiment, the proximal face 182 is fully closed when the stopper with a disinfectant. In one embodiment, the proximal face 182 is fully closed when the stopper

160 is not in use, and has a reversibly openable slit 181 in a central portion of the face 182. In this 160 is not in use, and has a reversibly openable slit 181 in a central portion of the face 182. In this

case the walls of the slit 181 preferably contact one another when the elastic material of the case the walls of the slit 181 preferably contact one another when the elastic material of the

stopper 160 is relaxed (i.e. when the stopper 160 is not in use) in order to close the opening in the stopper 160 is relaxed (i.e. when the stopper 160 is not in use) in order to close the opening in the

proximal end proximal end162 162ofofthe the stopper stopper 160 160 and andprevent preventcontamination contaminationofofthe thepresent present device. device. The Thewalls walls

of the slit 181 can be urged open when a syringe or other fluid conduit presses against the of the slit 181 can be urged open when a syringe or other fluid conduit presses against the

proximal face proximal face 182 182of of the the stopper stopper 160. 160.

[0096]

[0096] Additional slits 181 can be included in the face 182, for example two slits Additional slits 181 can be included in the face 182, for example two slits

intersecting to form an "x" can be used. intersecting to form an "X" can be used.

100971

[0097] In order to better retain the elastic stopper 160 within the female Luer body 100, In order to better retain the elastic stopper 160 within the female Luer body 100,

- 118-

the stopper 160 is the provided with is provided with aa retaining retaininggroove groove 184 184 having an inwardly having an extending annular inwardly extending annular

wall 185, wall 185,preferably preferablyat at thethe distal distal endend 164 164 of stopper of the the stopper The retaining 160.retaining 160. The groove groove 184 184 surrounds surrounds

the annular the annularflange flange141141 of the of the channel channel insert insert 150 Fig. 150 (see (see20) Fig.such 20)that such that a distally a distally facing, facing, outwardly outwardly

extending distal extending distal wall wall 141a 141a is isengaged engaged by a proximally facing, inwardly proximally facing, inwardly extending surface 185 extending surface 185 of of

the retaining the retaininggroove groove184184 and and restrains restrains the lateral, the lateral, andparticular and in in particular proximal, proximal, movement movement of the of the

stopper160. stopper 160.InInaddition, addition,thethe exterior exterior 165 165 of stopper of the the stopper 160 is160 is preferably preferably providedprovided with an with an

outwardly extending, outwardly extending, annular annularprojection projection 186 186 having havinga aproximal proximalface face187 187which whichis isadapted adaptedtoto

engage the engage the inwardly inwardly extending extendingwall wall114 114ofofthe the interior interior 101 101 of the the female female Luer Luer body 100 (see body 100 (see Fig. Fig.

20.) This 20.) This further further restrains restrainsthe proximal the proximalmovement ofthe movement of the stopper stopper 160. 160.

[00981

[0098] femaleLuer The female The Luerbody body100100 andand channel channel insert150150 insert areplaced are placedininfluid fluid

communicationwith communication with themale the male Luer Luer member member 20 of20the of the malemale Luer Luer body body 10avia 10 via a seal seal 170 (see 170 (see Figs. Figs.

28-32), which 28-32), whichis is preferably preferably formed formed from from an an elastomeric elastomeric or other or othermaterial elastic elastic such material such as as silicone. silicone.

The seal The seal 170 170 preferably preferably has has aa generally cylindrical cylindricalshape shapewith witha afluid fluidflow flowpassageway 171 passageway 171

extendingfrom extending from an off-center an off-center positioned positioned proximal proximal end 172 end to an172 to analigned axially axially aligned distal distal end 174. end 174.

Theoff-center The off-centeropening opening 179theinproximal 179 in the proximal face face 178 178the aligns aligns fluidthe fluid flow flow171channel channel with the171 with the

channeldistal channel distalopening opening143 143 of channel of the the channel insertinsert 150 in 150 intoorder order allowtoa allow flow ofa fluid flow through of fluidthe through the

connector assembly connector assembly1.1.

[00991

[0099] Theseal The 170 seal170 is is preferably preferably partially partially compressed betweenbetween compressed thesurface the distal distal 151 surface of 151 of

the channel the channelinsert insert150150 andand the the wallwall at the at the distal distal end end 44 of44 theofmale the Luer malebody Luer 10.body 10. 170 The seal Thehas seal 170 has

at least at least one axially extending one axially extending groove groove 173itsonannular 173 on its annular surfacesurface which which mates mates with withoneat at least least one

axially extending axially extending seal seal pegpeg 41 the 41 in in the malemale Luer Luer body body 40 40 intoorder in order to rotation prevent prevent of rotation of170. the seal the seal 170.

In addition, In addition, ananaxially axiallyextending, extending, annular annular flange flange or 175 or ring ringis175 is provided provided on theface on the distal distal 176 face of 176 of

the seal the seal 170. 170.The flange The flange 175 175 fitsfits within within the the groove groove 49 in 49 the in the receptacle receptacle 40male 40 of the of the Luermale body Luer body

- 19-

10 in 10 in the the manner manner of of an an O-ring, O-ring, in order in order to maintain to maintain a seal aat seal at higher higher pressures. pressures. The175flange The flange also 175 also

theseal allowsthe allows seal170170 to to maintain maintain a seal a seal fluid fluid whenwhen flow flow in in either either direction direction through through the the present present

connectorassembly connector assembly 1, also 1, and and also helpshelps to prevent to prevent fluidpassing fluid from from passing around thearound therather seal 170 seal than 170 rather than

through the through the flow passageway171. flow passageway 171.

[00100]

[00100] Connector Assembly Connector Assembly

[001011

[00101] To assemble To assemblethe thepresent present connector connectorassembly assembly1,1,the thestopper stopper160 160isis placed placed around around

the channel the channelinsert insert150, 150, andand this this subassembly subassembly is placed is placed throughthrough theend the distal distal endthe104 104 of of the female female

Luer body Luer body100 100totoform forma afemale femaleLuer Luersubassembly. subassembly. TheThe seal seal 170170 is is thenplaced then placedininthe thedistal distal end end

44 ofofthe 44 the receptacle receptacle4040 of of thethe male male LuerLuer body body 10 such10 such that thethat the 175 flange flange 175 is is seated seated within thewithin the

groove4949in inthethe groove receptacle receptacle 40 and 40 and the seal the seal pegs pegs 41 are41 are retained retained by the 173, by the grooves grooves 173, thereby thereby

forming aa male forming male Luer Luersubassembly. subassembly.The The female female Luer Luer subassembly subassembly can then can then be joined be joined to the to the male male

Luer subassembly Luer subassemblybybyplacing placingthe thedistal distal end end 104 104 of ofthe the female female Luer Luer body body100 100within withinthe theproximal proximal

end 12 end 12 of of the male Luer body male Luer body1010such suchthat that the the cam campost post110 110ononthe the female femaleLuer Luerbody body100100 is is

placed within the placed the cam groove5050ofofthe cam groove the male male Luer Luerbody body10.10.The Thefemale female Luer Luer body body 100 100 can can thenthen

be rotated be rotatedininorder ordertotosecure secure thethe subassemblies subassemblies to onetoanother. one another.

[001021

[00102] Exceptasasdescribed Except described otherwise otherwise herein herein with respect with respect to the to the stopper stopper 160 170, 160 and seal and seal 170,

the components the components ofofthe the connector connectorassembly assembly1 can I canbebemade made of of anyany suitablyrigid suitably rigidmaterial materialused usedfor for

medicalapplications, medical applications, such such as polycarbonate as polycarbonate or medical or other other medical grade grade plastic. plastic.

[001031

[00103] In the In the first first embodiment, embodiment, thethe outer outer surface surface 121 121 of theof the flange flange 120 of 120 of the Luer the female female Luer

body 100 body 100included includedthe theembossed embossed word word "Close." "Close." At rest At rest with with thethe valve valve I closed,the 1 closed, theword word "Close" "Close"

is not is be covered not be coveredbyby thethe semi-annular semi-annular shieldshield 60, thereby 60, thereby visually visually indicating indicating that the that valvethe valve 1 was in I was in

its closed its position. Upon closed position. Upon being being engaged engaged by an device by an access accesstodevice to twist twist the valve the valve 1 open, theI shield open, the shield

60 rotates 60 rotates over overandand therefore therefore conceals conceals the word"Close," the word "Close," thereby thereby visually visually indicatingindicating that that the valve the valve

20-

Jul 2023

wasininits was its open openposition. position.

2023208151 27

[00104]

[00104] In lieu of the visual indication of the first embodiment, as shown in Fig. 33 B & C, In lieu of the visual indication of the first embodiment, as shown in Fig. 33 B & C,

in the second and third embodiments, there is provided a bold triangular first indicator 200, in the second and third embodiments, there is provided a bold triangular first indicator 200,

preferably colored "green" that is formed on the lateral side 18 of the male Luer body 10. A preferably colored "green" that is formed on the lateral side 18 of the male Luer body 10. A

second bold triangular indicator 202, preferably colored "green" is formed on the outer surface second bold triangular indicator 202, preferably colored "green" is formed on the outer surface

121 of flange 120 of the channel insert 150. The indicators 200 and 202 are diametrically 121 of flange 120 of the channel insert 150. The indicators 200 and 202 are diametrically

opposed when the valve I is in its closed position and are aligned when the valve I is in its open opposed when the valve 1 is in its closed position and are aligned when the valve 1 is in its open

position due to the 180 degree path of the cam groove 50, thereby visually indicating the open or position due to the 180 degree path of the cam groove 50, thereby visually indicating the open or

closed state of the valve 1. Moreover, unlike the first embodiment, the indicators 200 and 202 closed state of the valve 1. Moreover, unlike the first embodiment, the indicators 200 and 202

that precisely align when the valve I is open, clearly indicating when the valve I is fully open. that precisely align when the valve 1 is open, clearly indicating when the valve 1 is fully open.

[00105]

[00105] In a variation to the second and third embodiments, a pair of diametrically In a variation to the second and third embodiments, a pair of diametrically-

opposedgreen-colored opposed green-coloredindicators indicators 200 200and and202202are areformed formedonon thelateral the lateral side side 18 18 and and outer outer surface surface

121. Another pair of indicators 204, preferably colored "red" are formed on the lateral side 18 of 121. Another pair of indicators 204, preferably colored "red" are formed on the lateral side 18 of

the male the Luer body male Luer body1010atat aa smaller smaller angular angular distance distance (e.g., (e.g.,120 120degrees). degrees).The The cam groove 5050isis cam groove

formed at the same angular distance to define a lesser angular path (e.g., 120 degrees). When the formed at the same angular distance to define a lesser angular path (e.g., 120 degrees). When the

valve I is closed, the green indicators 202 on the outer surface 121 of flange 120 are aligned with valve 1 is closed, the green indicators 202 on the outer surface 121 of flange 120 are aligned with

the red indicators 104 on the lateral side 18 of the male Luer body 10 , thereby visually indicating the red indicators 104 on the lateral side 18 of the male Luer body 10, thereby visually indicating

that the valve I is closed. However, when the valve I is open, the green indicators 202 on the that the valve 1 is closed. However, when the valve 1 is open, the green indicators 202 on the

outer surface 121 of flange 120 are aligned with the green indicators200 on the lateral side 18 of outer surface 121 of flange 120 are aligned with the green indicators 200 on the lateral side 18 of

the male Luer body 10, thereby visually indicating that the valve 1 is open. It is noted that having the male Luer body 10, thereby visually indicating that the valve 1 is open. It is noted that having

the indicators 200, 202 and 204 positioned at 120 degrees increases the visibility at all angles and the indicators 200, 202 and 204 positioned at 120 degrees increases the visibility at all angles and

due to their precise alignments, precisely visually indicate when the valve I is fully open or fully due to their precise alignments, precisely visually indicate when the valve 1 is fully open or fully

closed. closed.

- 21

[001061

[00106] Although Although thethe present present invention invention has been been described has described in considerable in considerable detail detail with with

reference to reference to certain certainpreferred preferredembodiments, other embodiments embodiments, other arepossible. embodiments are possible. Therefore, Therefore, the the scope scope

of the of the appended claims should appended claims shouldnot not be be limited limited to to the the description descriptionof ofpreferred preferredembodiments embodiments

2023208151

containedininthis contained thisdisclosure. disclosure.Recitation Recitation of value of value ranges ranges hereinherein is merely is merely intendedintended to serve to as serve a as a

shorthandmethod shorthand method for referring for referring individually individually toseparate to each each separate value within value falling fallingthe within range.the range. Unless Unless

otherwiseindicated otherwise indicated herein, herein, eacheach individual individual value value is incorporated is incorporated into theinto the specification specification as if as if it were it were

individuallyrecited individually recitedherein. herein.AllAll references references cited cited herein herein are incorporated are incorporated by reference by reference in their in their

entirety. entirety.

[001071

[00107] What claimed Whatisisclaimed is: is:

Claims

CLAIMS 30 May 2025 2023208151 30 May 2025 CLAIMS

1. 1. A medical A medicalconnector connectorassembly assembly having having a longitudinal a longitudinal axis,the axis, themedical medicalconnector connector assemblycomprising: assembly comprising: aa male luer body male luer havingaa proximal body having proximalend, end,aadistal distal end, end, and and a a flow flow channel extending channel extending

betweensaid between saidproximal proximalend endand andsaid saiddistal distal end, end, said said distal distalend end comprising a tapered comprising a tapered male luer male luer 2023208151

memberhaving member having an an open open endend adapted adapted to be to be connected connected to atofluid a fluid conduit; conduit;

a female a luer assembly, female luer comprising:aafemale assembly, comprising: femaleluer luer body bodyhaving havinga aproximal proximal end,a end, a distal distalend, end,and and aaflow flow channel channel extending extending between saidproximal between said proximalend endofofsaid saidfemale femaleluer luerbody body and said distal end of said female luer body, said proximal end of said female luer body and said distal end of said female luer body, said proximal end of said female luer body

forming forming aa female femaleluer luer member member forreceiving for receivinga amale maleluer luermember member offluid of a a fluid transferdevice; transfer device; said female said luer body female luer comprisinga acam body comprising campost; post; a fluid channel insert having a proximal end, a distal end, and a flow channel a fluid channel insert having a proximal end, a distal end, and a flow channel

extending between said proximal end of said fluid channel insert and said distal end of said extending between said proximal end of said fluid channel insert and said distal end of said

fluid channelinsert, fluid channel insert,wherein whereinsaidsaid flowflow channel channel of saidoffluid saidchannel fluid channel insert isinsert offsetisfrom offset saidfrom said

longitudinal axis at said distal end of said fluid channel insert, said fluid channel insert further longitudinal axis at said distal end of said fluid channel insert, said fluid channel insert further

comprising an annular medial wall at said distal end of said fluid channel insert, said annular comprising an annular medial wall at said distal end of said fluid channel insert, said annular

medial wall engaging said distal end of said female luer body, said proximal end of the fluid medial wall engaging said distal end of said female luer body, said proximal end of the fluid

channel insert comprising channel insert comprising aa tubular tubular conduit conduit having an opening having an openingatat aa proximal proximalend endofofsaid said tubular conduit, and said fluid channel insert further comprises an annular barb shaped flange tubular conduit, and said fluid channel insert further comprises an annular barb shaped flange

extending outwardly extending outwardlyfrom fromsaid saidtubular tubularconduit conduitbetween betweenan an outwardly outwardly extending extending medial medial wallwall

and said proximal end of said fluid channel insert; and said proximal end of said fluid channel insert;

an an elastomeric seal having elastomeric seal a proximal having a end, aa distal proximal end, distal end, end,and and aaflow flow channel channel extending extending

between said proximal end of said elastomeric seal and said distal end of said elastomeric between said proximal end of said elastomeric seal and said distal end of said elastomeric

seal, wherein said flow channel of said elastomeric seal is offset from said longitudinal axis at seal, wherein said flow channel of said elastomeric seal is offset from said longitudinal axis at

said proximal said end of proximal end of said said elastomeric seal and elastomeric seal and is is adapted adapted to to provide provide fluid fluidcommunication communication

with said flow channel of said fluid channel insert at said distal end of said fluid channel with said flow channel of said fluid channel insert at said distal end of said fluid channel

insert; insert; and and

an an elastomeric stopper having elastomeric stopper having aa proximal proximalend endand anda adistal distal end, end, said said elastomeric elastomeric

stopper having stopper having a flush a flush surface surface at said at said proximal proximal end of end saidof said elastomeric elastomeric stopper, stopper, said flush said flush

surface surface comprising comprising aa slit slit totoallow allowan anopening opening to to be be formed formed by deformingsaid by deforming saidproximal proximalend endofof said elastomeric said elastomeric stopper, stopper, said said elastomeric elastomeric stopper stopper further furthercomprising comprising an an annular annular groove groove

adapted to mate with said annular barb shaped flange of said fluid channel insert; and adapted to mate with said annular barb shaped flange of said fluid channel insert; and

- 23 whereinsaid said distal distal end end of of said saidfemale female luer luerbody body connects connects with with said said proximal end of of said said male 30 May 2025 2023208151 30 May 2025 wherein proximal end male luer luer body with an body with an interference interference fit fitand andforms forms aaflow flow channel channel through through said said medical connector medical connector assemblywhen assembly when saidflow said flowchannel channel of of saidmale said male luerbody luer body andand said said flow flow channel channel of of said said female female luer bodyare luer body arealigned; aligned; whereinthe wherein the proximal proximalend endofofsaid saidmale maleluer luerbody bodyfurther furthercomprises comprisesa acam cam groove groove andand aa protrusion, protrusion, said saidprotrusion protrusionextending extending into intothe thecam cam groove groove at at each each end end of of the the cam cam groove, groove, said cam said grooveextending cam groove extendingaround around a portionofofa acircumference a portion circumferenceofof theproximal the proximal end end of of the the 2023208151 male luer male luer body, body, said said cam groovebeing cam groove beingshaped shapedto to receivesaid receive saidcam cam postofofthe post thefemale femaleluer luer body and to define a range of rotation of the female luer body with respect to the male luer body and to define a range of rotation of the female luer body with respect to the male luer body, with body, with the the cam campost postsnapping snappingover overthe theprotrusion protrusiontoto retain retain the the female female luer luer body in one body in one of of aa fully fully engaged engaged position position and and a a disengaged position. disengaged position.

2. 2. Themedical The medicalconnector connectorassembly assembly of of claim claim 1, 1, furthercomprising further comprisinga, a, saidcap said caphaving having an an open proximalend, open proximal end,aaclosed closeddistal distal end, end, and and a a longitudinal longitudinal axis axisbetween between said said open open

proximalend proximal endofofsaid said cap cap and andsaid said closed closed distal distal end end of of said saidcap, cap,said saidopen openproximal proximal end end of of

said cap being sized to fit on said tapered male luer member of said male luer body. said cap being sized to fit on said tapered male luer member of said male luer body.

3. 3. The medical The medicalconnector connectorassembly assembly as as setset forthininclaim forth claim1,1, wherein whereinananexterior exterior surface ofsaid surface of saidelastomeric elastomeric stopper stopper and and an an interior interior surface surface of saidof said luer female female bodyluer body comprise comprise

interlocking interlocking walls walls precluding precluding removal of said removal of said elastomeric elastomeric stopper stopper from fromsaid said female femaleluer luer body. body.

4. 4. The medical The medicalconnector connectorassembly assembly as as setset forthininclaim forth claim1,1, where wheresaid saidproximal proximalend end of said fluid of said fluid channel channelinsert insert comprises comprises at least at least one longitudinal one longitudinal groove groove for grasping for grasping said said proximalend proximal endofofsaid said elastomeric elastomeric stopper stopper when whensaid saidproximal proximalendend ofof saidelastomeric said elastomericstopper stopper is deformed is radially outward deformed radially withinthe outward within the opening openingofofthe the tubular tubular conduit, conduit, thereby thereby hindering hindering

relative rotational relative rotationalmovement betweensaid movement between saidfluid fluid channel channelinsert insert and and said said elastomeric stopper elastomeric stopper

whenthe when themedical medicalconnector connectorisisaccessed accessedbybysaid saidmale maleluer luermember member of said of said fluidtransfer fluid transfer device. device.

5. 5. The medical The medicalconnector connectorassembly assembly as as setset forthininclaim forth claim4,4, wherein whereinthe theat at least least one one

longitudinal groove comprises a plurality of grooves oriented frustroconically. longitudinal groove comprises a plurality of grooves oriented frustroconically.

6. 6. The medical The medicalconnector connectorassembly assembly as as setset forthininclaim forth claim1,1, wherein whereinsaid saiddistal distal end end of of

said female luer body and said distal end of said fluid channel insert comprise interlocking said female luer body and said distal end of said fluid channel insert comprise interlocking

- 24 grooves and andprojections projections precluding precludingrelative relative rotation rotation between said female luer body andsaid said 30 May 2025 2023208151 30 May 2025 grooves between said female luer body and fluid channelinsert. fluid channel insert.

7. 7. The medical The medicalconnector connectorassembly assembly as as setset forthininclaim forth claim6,6, wherein whereinsaid saidinterlocking interlocking grooves areformed grooves are formed onoutside on an an outside surface surface of saidof saidchannel fluid fluid channel insert insert and said and said projections projections are are formedononananinside formed inside surface surface of of said said female luer body. female luer body. 2023208151

8. 8. Themedical The medicalconnector connectorassembly assembly as as setset forthininclaim forth claim6,6, wherein whereinsaid saidinterlocking interlocking grooves and grooves and said said projections projections are oriented are oriented frustroconically. frustroconically.

9. 9. The medical The medicalconnector connectorassembly assembly as as setset forthininclaim forth claim1,1, wherein whereinsaid saidcam campost postofof said female said luer body female luer and said body and said cam camgroove grooveofofsaid saidmale maleluer luerbody bodycomprise comprisean an interlocking interlocking

camgroove cam grooveand andananinterlocking interlockingcam cam postthat post thatpreclude precludeover-rotation over-rotationofofsaid said female femaleluer luer body body relative to said male luer body. relative to said male luer body.

10. 10. A medical A medicalconnector connectorassembly assembly having having a longitudinal a longitudinal axis,the axis, themedical medicalconnector connector assemblycomprising: assembly comprising: a male a luer body male luer havingaa proximal body having proximalend, end,aadistal distal end, end, and and a a flow flow channel extending channel extending

betweensaid between saidproximal proximalend endand andsaid saiddistal distal end, end, said said distal distalend end comprising a tapered comprising a tapered male luer male luer

a female a luer body female luer havingaa proximal body having proximalend, end,aadistal distal end, end, and and a a flow flow channel extending channel extending

betweensaid between saidproximal proximalend endofofsaid saidfemale femaleluer luerbody bodyand andsaid saiddistal distal end endof of said said female female luer luer body, said body, said proximal endofofsaid proximal end said female femaleluer luer body bodyforming forminga afemale femaleluer luermember memberforfor receiving receiving

a male a luer member male luer member ofofa afluid fluid transfer transfer device; device; said said female female luer luerbody body comprising comprising aa cam campost; post; aa fluid channelinsert fluid channel inserthaving having a proximal a proximal end, aend, a distal distal end, aend, flow achannel flow channel extendingextending

between said proximal end of said fluid channel insert and said distal end of said fluid between said proximal end of said fluid channel insert and said distal end of said fluid

channel insert, and an annular medial wall at said distal end of said fluid channel insert, said channel insert, and an annular medial wall at said distal end of said fluid channel insert, said

annular medial annular medialwall wall engaging engagingsaid saiddistal distal end of said end of said female female luer luer body; body; said said proximal end of proximal end of the fluid the fluid channel channel insert insertcomprising comprising aa tubular tubularconduit conduit having having an an opening at aa proximal opening at end of proximal end of said tubular conduit; said tubular conduit;

an elastomeric an seal having elastomeric seal a proximal having a end, aa distal proximal end, distal end, end,and and aaflow flow channel channel extending extending

seal, wherein said flow channel of said elastomeric seal is adapted to provide fluid seal, wherein said flow channel of said elastomeric seal is adapted to provide fluid

- 25 communication with said flow channel of said fluid channel insert at said distal end of said 30 May 2025 2023208151 30 May 2025 communication with said flow channel of said fluid channel insert at said distal end of said fluid channelinsert; fluid channel insert;and and an elastomeric an elastomeric stopper stopper having havingaa proximal proximalend endand anda adistal distal end, end, said said elastomeric elastomeric stopper having a flush surface at said proximal end of said elastomeric stopper, said flush stopper having a flush surface at said proximal end of said elastomeric stopper, said flush surface comprising surface comprising aa slit slit totoallow allowan anopening opening to to be be formed formed by deformingsaid by deforming saidproximal proximalend endofof said elastomeric said elastomeric stopper; stopper; and and wherein said distal wherein said distal end end of ofsaid saidfemale female luer luerbody body connects connects with with said proximal said end of proximal end of said said male luer body male luer withan body with aninterference interference fit fit and and forms forms aa flow flow channel channel 2023208151 through said through said medical medicalconnector connectorassembly assembly when when said said flow flow channel channel of said of said male male luerluer body body and and said flow channel of said female luer body are aligned; said flow channel of said female luer body are aligned; whereinthe wherein the proximal proximalend endofofsaid saidmale maleluer luerbody bodyfurther furthercomprises comprisesa acam cam groove groove andand a protrusion, said protrusion extending into the cam groove at each circumferential end of the a protrusion, said protrusion extending into the cam groove at each circumferential end of the camgroove, cam groove,said saidcam camgroove groove extending extending around around a portion a portion of of a circumference a circumference of of thethe proximal proximal end of end of the the male luer body, male luer body, said said cam groovebeing cam groove beingshaped shapedtotoreceive receivesaid saidcam campost postofofthe the female luerbody female luer body and and to define to define a range a range of rotation of rotation of the of the female female luer bodyluer withbody with respect to respect the to the male luer male luer body, body, with with the the cam campost postsnapping snappingover overthe theprotrusion protrusiontoto retain retain the the female female luer luer body body in in one ofaafully one of fullyengaged engaged position position and and a a disengaged disengaged position. position.

11. 11. A medical A medicalconnector connectorassembly assembly having having a longitudinal a longitudinal axis axis comprising: comprising:

a male a luer body male luer bodyhaving havinga aproximal proximal end, end, a distalend, a distal end, andand a flow a flow channel channel extending extending

betweensaid between saidproximal proximalendend and and distal distal end,end, saidsaid distal distal endend comprising comprising a tapered a tapered male male luer luer memberhaving member having an an open open endend adapted adapted to be to be connected connected to atofluid a fluid conduit; conduit;

aa female luer assembly, female luer comprising: assembly, comprising:

a female a female luer luer body bodyhaving having a proximal a proximal end,end, a distal a distal end, end, and and a flow a flow channel channel

extending between extending betweensaid saidproximal proximal end end andand distalend, distal end,said saidproximal proximal end end of of saidfemale said female luer luer body forminga afemale body forming femaleluer luermember memberfor for receiving receiving a male a male luerluer member member of a fluid of a fluid

transfer device; transfer device; said saidfemale female luer luerbody body comprising comprising aa cam post; cam post;

aa fluid fluid channel channel insert insert having having a a proximal end, aa distal proximal end, distal end, end, and a flow and a channel flow channel

extending between extending betweensaid saidproximal proximalend end and and saiddistal said distalend, end,wherein whereinsaid saidflow flowchannel channelofof said fluid channel insert is offset from said longitudinal axis at said distal end of said said fluid channel insert is offset from said longitudinal axis at said distal end of said

fluid channelinsert, fluid channel insert,said saidfluid fluidchannel channel insert insert further further comprising comprising an annular an annular medial wall medial wall

at at its its distal distal end, said annular end, said annularmedial medial wallwall engaging engaging said end said distal distal end female of said of saidluer female luer body; body;

said proximal said endof proximal end of the the channel channel insert insert comprising comprising aa tubular tubular conduit conduit having havingan an opening at its proximal end; opening at its proximal end;

- 26 said fluid channel channelinsert insert further further comprises comprisesan an annular barbbarb shaped flangeflange 30 May 2025 2023208151 30 May 2025 said fluid annular shaped extending outwardly extending outwardlyfrom fromsaid saidtubular tubularconduit conduitbetween betweenananoutwardly outwardly extending extending medial medial wall and said proximal end of said fluid channel insert; wall and said proximal end of said fluid channel insert; an elastomeric seal an elastomeric seal having havinga aproximal proximal end, end, a distalend, a distal end,andand a flow a flow channel channel extending between extending betweensaid saidproximal proximalend end and and distalend, distal end,wherein whereinsaid saidflow flowchannel channelofofsaid said seal is offset from said longitudinal axis at said proximal end and is adapted to provide seal is offset from said longitudinal axis at said proximal end and is adapted to provide fluid fluid communication withsaid communication with saidflow flow channel channel of of said said fluidchannel fluid channel insertatatsaid insert saiddistal distal 2023208151 end of said fluid channel insert; and end of said fluid channel insert; and an elastomeric stopper an elastomeric stopperhaving havinga aproximal proximal endend and and a distal a distal end,end, saidsaid stopper stopper having a flush surface at its proximal end, said flush surface comprising a slit to allow having a flush surface at its proximal end, said flush surface comprising a slit to allow an opening an openingtotobebeformed formed by by deforming deforming said said proximal proximal end, elastomeric end, said said elastomeric stopper stopper further comprising further anannular comprising an annulargroove grooveadapted adapted to to mate mate with with said said annular annular barbbarb shaped shaped flange ofsaid flange of saidfluid fluidchannel channel insert; insert; andand whereinsaid wherein said distal distal end of said end of said female luer assembly female luer connectswith assembly connects withsaid saidproximal proximalendend of said of said male male luer luer body with an body with an interference interference fit fitand andforms forms aa flow flow channel channel through said medical through said medical connector assembly connector assemblywhen when said said flow flow channels channels areare aligned, aligned, whereinthe wherein the proximal proximalend endofofsaid saidmale maleluer luerbody body furthercomprises further comprises a cam a cam groove groove and and protrusions, said protrusions extending into the cam groove at each end thereof, protrusions, said protrusions extending into the cam groove at each end thereof, said cam said grooveextending cam groove extendingaround around a portion a portion of of thecircumference the circumference of of thethe proximal proximal endend of of the the male male luer luer body and being body and being shaped shapedtoto receive receive said said cam campost postof of the the female female luer luer body, body, said insert said insert comprising comprising ananinterlocking interlockinggroove groove andand a projection a projection precluding precluding relative relative rotation between said female luer body and said fluid channel insert, and rotation between said female luer body and said fluid channel insert, and whereinsaid wherein saidgroove grooveisisformed formedon on thethe annular annular distalwall distal wallofofsaid saidfluid fluidchannel channelinsert insert instead ofthe instead of theannular annularmedial medial wall, wall, the the projection projection is longitudinally is longitudinally extended extended from thefrom thewall distal distal wall of the female of the female luer luer body bodyand and projected projected toward toward a distal a distal direction, direction, thethe interlocking interlocking groove groove is is engagedbybythe engaged theprojection. projection.

12. 12. The The medical medical connector connector assembly assembly of claim of claim 11, further 11, further comprising comprising a cap, a cap, said said cap cap having having

an open an proximalend, open proximal end,aaclosed closeddistal distal end, end, and and a a longitudinal longitudinal axis axistherebetween, therebetween, said saidproximal proximal

end being end being sized sized to to fit fiton onsaid saidmale maleluer luermember of said member of said male luer body. male luer body.

13. 13. The The medical medical connector connector as setasforth set forth in claim in claim 11, wherein 11, wherein an exterior an exterior surfacesurface of saidof said stopper andanan stopper and interior interior surface surface of said of said female female luer luer body body comprise comprise interlocking interlocking walls precluding walls precluding

removalofof said removal said stopper stopper from fromsaid said female femaleluer luer body. body.

- 27

2023208151 30 May 2025

14. 14. The The medical medical connector connector as setasforth set forth in claim in claim 11, where 11, where a proximal a proximal end fluid end of said of said fluid channel insertcomprises channel insert comprises at least at least one one longitudinal longitudinal groovegroove for grasping for grasping said proximal said proximal end of saidend of said

stopper and hinder stopper and hinder relative relative rotational rotationalmovement therebetween movement therebetween when when the the medical medical connector connector is is

accessed by aa male accessed by maleluer luer member member ofof a afluid fluidtransfer transfer device. device.

15. 15. The The medical medical connector connector as setasforth set forth in claim in claim 14, wherein 14, wherein the atthe at least least one longitudinal one longitudinal 2023208151

groove comprises groove comprises a plurality a plurality of grooves of grooves oriented oriented frustroconically. frustroconically.

16. 16. The The medical medical connector connector asforth as set set forth in claim in claim 11, 11, wherein wherein said said interlocking interlocking grooves grooves and and projections are oriented frustroconically. projections are oriented frustroconically.

17. 17. The The medical medical connector connector asforth as set set forth in claim in claim 11, wherein 11, wherein said said cam of cam post post of female said said female luer luer body andsaid body and said cam camgroove groove of of saidmale said male luer luer body body comprise comprise an interlocking an interlocking cam groove cam groove

and an and an interlocking interlocking cam campost postthat thatpreclude precludeover-rotation over-rotationofofsaid said female femalebody bodyrelative relativetotosaid said male luer male luer body. body.

Halkey-Roberts Corporation Halkey-Roberts Corporation Patent Patent Attorneys Attorneys for forApplicant/Nominated Applicant/Nominated Person Person SPRUSON&FERGUSON SPRUSON&FERGUSON

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2023208151 27 Jul 2023208151

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